Senior Manager, QA Resume Samples

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A Johnson

Alta

Johnson

9433 Rodger Vista

New York

+1 (555) 903 9335

9433 Rodger Vista

New York

Phone

p +1 (555) 903 9335

Experience Experience

Phoenix, AZ

Senior Manager, QA

Phoenix, AZ

Streich-Ullrich

Phoenix, AZ

Senior Manager, QA

Develops and manages internal departmental audit programme in conjunction with Operational Management
Oversee and manage a small internal QA team. Create and execute general and specific test plans to ensure proper testing of all features and aspects of games
Monitor and evaluate the performance of all team members, ensuring that they can always perform at the highest levels
Provides management with plans and status updates on assigned responsibilities and goals and escalates issues in a timely fashion
Manage the execution of the daily build process so as to ensure daily development operations
Ensure all necessary training is provided to auditors to improve their job performance and knowledge. Provide coaching/mentoring and a benchmark of auditing competencies, as necessary
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; Establishes and supports best practices for problem solving, root cause analysis, and solution selection tools

New York, NY

Senior Manager QA / Testing

New York, NY

Schulist, Hettinger and Heller

New York, NY

Senior Manager QA / Testing

Define the Payments testing strategy, delivery framework and oversee the execution of all payments testing workstreams
Building and maintaining a central repository of test data across the multiple line of businesses
Continuously enhance testing knowledge/expertise and keep current with leading-edge technology trends
Develop process of maintaining gold copy of test data sets for programs, projects and mini-releases
Promote and develop awareness of testing methodologies and standards
Provide expert consulting services to other areas of IT and the Business
Identify and recommend opportunities to enhance productivity, effectiveness and operational efficiency of the business unit and/or team

present

Detroit, MI

Senior Manager QA for R & D Research & Pre-clinical

Detroit, MI

Hills and Sons

present

Detroit, MI

Senior Manager QA for R & D Research & Pre-clinical

present

Responsible for coaching, training, motivating and evaluating his/her direct reports through effective performance KPI’s
Develop, assure and maintain the quality of the vaccine research and pre-clinical testing processes
Make sure that Business Monitoring (self-inspection) are performed,
Ensure a continuous quality & compliance improvement mindset within his/her remit
Define quality audit programs and follow-up on their implementation
Organize and take the responsibility for Quality Assurance in Research & Pre-Clinical activities for R&D Department
Establish SOP’s for quality standard in collaboration with other departments and based on Global Quality Assurance and or corporate policies

Education Education

Bachelor’s Degree in Science

East Carolina University

Bachelor’s Degree in Science

Skills Skills

Strong people management and communication skills with the ability to Influence others and gain commitment
Highly developed problem solving skills and the ability to resolve difficult conflicts
Cost consciousness, with good commercial awareness and customer focus
In depth knowledge and understanding of drug development, clinical trial and drug safety processes
Demonstrated training skills, including the ability to give constructive feedback
Ability to multitask and to work efficiently and independently under pressure
Team building and leadership skills
A satisfactory progression of auditing experience with experience in leadership and QA management
EU/AsiaPac: in depth proven experience in a quality/regulatory pharmacovigilance compliance position, with a proven track record of success in managing quality projects and teams with broad quality assurance experience

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15 Senior Manager, QA resume templates

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Senior Manager, QA & Automation Resume Examples & Samples

Development, management and leadership of overall software QA group
Lead the QA teams in defining and implementing quality assurance and automation strategies / practices with optimal return on investment
Ongoing evaluation of test automation technologies and practices and evolving/implementing department standards
Motivate, manage and lead QA managers and engineers from daily guidance and feedback to career planning
Develop and manage quality assurance metrics during development cycles and for production systems
Mana4Age the planning and execution of product testing efforts, including all associated resources to meet committed delivery dates
Participate in all activities of the development process, from release/sprint planning to demos and retrospectives
Embrace a hands-on approach to leading the team through example, which may include writing test cases, automation scripts and manual testing
Articulate the state of product quality across multiple product verticals to executive management and business stakeholders
Participate in improving the overall software development processes in participation with engineering managers, project managers, and other key stakeholders
Collaborate with software engineers on implementing automation on an ongoing basis as part of regular sprints
Ability to find creative solutions to complex testing and feature delivery issues
Works to develop relationships with group leads and executives to help improve product delivery and quality
This position requires healthy doses of initiative and the ability to remain flexible and responsive in a very dynamic environment
Thorough understanding of quality management and modern testing techniques, methodologies, processes, procedures and measurement for large, complex initiatives
Possess a "Do what it takes" attitude with the flexibility to multi-task if needed and be willing to contribute to hands-on test efforts when needed
Experience in using or implementing test automation and load testing tools such as Selenium, JMeter, WebTest, Load Runner, Apica, etc…)
Understanding of testing on connected devices and mobile devices (iOS, Android, Windows, Blackberry, Apple TV, Roku, XBox)
Strong experience in creating test plans, test cases, and test strategies for high availability products or web sites
Knowledge of content delivery networks (CDNs) preferred
Knowledge of Java programming fundamentals is a plus
Proven experience motivating and growing QA teams in a dynamic environment
Experience with managing multiple QA teams under different product verticals
Ability to track and report on testing progress across multiple products and initiatives
Proven abilities in using Confluence and Jira
Strong leadership skills that inspire team confidence and motivation
BA/BS degree or equivalent experience with at least 3+ years as a manager or director in a QA team and 8+ years in software QA or development

Senior Manager, QA Resume Examples & Samples

Manage and lead day-to-day, developer-focused quality-assurance operations
Oversee and manage a small internal QA team. Create and execute general and specific test plans to ensure proper testing of all features and aspects of games
Continually provide excellent quality assurance in a highly dynamic environment by abiding by QA best practices and principles
Manage one or multiple defect-tracking databases and provide training to both development team and QA team users as needed
Act as point of contact for external testing teams and train them in our internal testing procedures either onsite or remotely as needed
Manage the relationship with external or offsite testing groups
Manage the execution of the daily build process so as to ensure daily development operations
Ensure quality on all internal and external India Games releases
Be directly involved with reviewing and hiring new QA staff
Monitor and evaluate the performance of all team members, ensuring that they can always perform at the highest levels
Be an internal advocate and spokesperson for all things QA. Identify and clearly communicate issues, risks, concerns, and successes to stakeholders
Conduct usability, functionality, performance, and load testing as needed
In collaboration with external testing partners, build schedules and budgets to test games and meet them
Continually improve the operational efficiency and effectiveness of the QA effort by assessing current quality-assurance practices, understanding the needs of the development team, and incorporating new strategies

Senior Manager, QA & Compliance, Home Resume Examples & Samples

Manage the Testing process to insure that all styles that require it are tested and pass with satisfactory results and all CPSIA test are being captured
Manage the testing team to test with the objective being to control test cost while testing all product that requires the same
Manage that all test protocols are sent out globally to all vendors
Explain the testing process / procedures to all new vendors up front. That entails sending them the following information

Senior Manager QA Process Transformations Resume Examples & Samples

Define innovative Quality Assurance and Testing Framework that leverages multiple methodologies(Agile, Iterative, Waterfall) as appropriate to drive accelerated delivery and infuse testability early in the SDLC process by building testability into solutions
Evaluate and assess existing Agile processes, techniques and methods in the spirit of continuous improvement, value delivery and establishment of Agile standards and best practices
Define, implement and operationalize an overall Agile and Team "Health" framework to understand how we are doing within our dedicated Teams as it relates to quality, productivity, stability, value delivery and other dimensions
Contribute to Agile training curriculum as well as introduce, develop and deliver new training curriculums and workshops
Manage/lead a team of Agile Practices + Tools Manager as well as Resource & Capacity Planning Manager across Qulaity Assurance Teams
A minimum of 5 years of project management experience (as a Sr. Project Manager or Sr. Technical Team Lead)
Maturity, judgment, negotiation/influence/analytical/leadership skills are essential
Experience across multiple technology platforms including Agile engineering practices (Continuous Integration)
Detail oriented with excellent problem solving skills, including the ability to deal with situations where information is difficult to obtain, complex or ambiguous
Significant demonstrated expertise with Automated Unit Testing and Continuous Integration platforms and processes
Excellent written, verbal, presentation and facilitation skills necessary to effectively convey goals and initiatives to team members and top management. Extensive experience in direct customer contact and presentations
Strong organizational, leadership, decision making and creative problem-solving skills
The ability to manage multiple projects to tight timelines, attention to detail and a disciplined ability to prioritize
Proactive, energetic, professional self-starter with excellent communication and interpersonal skills, and the ability to work effectively in cross-functional teams

Senior Manager, QA Resume Examples & Samples

Must have a strong background in Quality Assurance (Functional, Automation or Performance Testing)
Must have experience using test tools such as HP ALM or HP Quality Center, QuickTest Pro (QTP) or UFT, SOA, Parasoft, Mercury LoadRunner
Must have experience writing scripts
Presentations--Ability to present information to groups with the appropriate degree of formality
Interpersonal Relationships--Knowledge of approaches, tools and techniques for working with individuals and groups in a constructive and collaborative manner
Decision Making and Critical Thinking--Knowledge of tools and techniques for effective use of a broad range of factors, assumptions, frameworks and perspectives when solving problems
Conflict Management--Knowledge of tools and techniques for anticipating, recognizing and effectively dealing with existing or potential conflicts at the individual, group or situation level
Staff and Career Development--Ability to address training and career development needs of individuals, teams or organization
Leadership--Knowledge of approaches, tools, and techniques for gaining the cooperation and support of others

Senior Manager QA Year Contract Resume Examples & Samples

University Degree, Professional certification in the fields of QA, Project Management or Business is an asset
More than 10 years of work experience with minimum 5 years in manager roles
Proven leadership skills to direct large groups at varying levels (may include managers, project leaders, and testers) towards common objectives
Excellent organizational, analytical and forward thinking skills to coordinate both complex code testing schedules
Expert understanding of SIT and UAT standards and methodology
Expert understanding of code library management
Expert understanding of multiple test environments and their relationship to code delivery and business functions
Good understanding of the relationship data warehousing tools, concepts and techniques including ETL, SQL, Scheduler, Business Objects, Cognos, DB2, Informatica, etc
Effective written and verbal communication skills
Solid understanding of and proven experience with QA techniques such as requirements management and automation
Very experienced with testing approaches - black, white, grey box, regression, scenario-based, model-based, and more
Experience working in Planview is an asset

Senior Manager QA / Testing Resume Examples & Samples

Define the Payments testing strategy, delivery framework and oversee the execution of all payments testing workstreams
Recruit and develop a team of skilled testing resources
Manage business partner relationships to support delivery of excellent customer service
Develop and manage operational processes that are consistent across the portfolio; ensure testing processes are incorporated into overall technology delivery practices and standards
Provide expert consulting services to other areas of IT and the Business
Implement quality, operational, and service management processes and ensure adherence to the processes
Develop and manage the departmental plan and budget to ensure effective use of corporate funds and compliance with budget targets and outsource vendor contract terms and conditions
Manage intake and demand, coordinating testing resources as required; identify and source appropriate resources across all work streams, ensure all resources are used effectively
Participate in audit reviews of testing practices when required
Grow team expertise to align with enterprise demand and the Bank's business / technology direction; assess team skills and capabilities and continually look for ways to provide and enhance the value delivered
Foster an environment / culture that encourages productivity, innovation, process improvement, teamwork and a high level of professionalism
Provide coaching, development, succession, recruitment, resource management and overall team leadership for team members and provide regular input into team members’ assessment of performance and development plans
Identify and recommend opportunities to enhance productivity, effectiveness and operational efficiency of the business unit and/or team
Set and manage performance metrics
Set strategy and direction at an operational level, work autonomously in the management of the unit and collaborate with other business heads to establish and execute on common goals
Understand strategic direction and champion alliances to benefit the Bank and/or department
Direct the development of resolutions, plans and strategies for operational advancement

Senior Manager QA / Testing Resume Examples & Samples

Leading teams that consist of FTE, vendors and contractors located across various geographic locations
Understanding and delivering upon client's needs
Strategy development and the implementation of roadmaps
Analysis, decision-making and problem-solving
Delivering results under pressure
Interpersonal relationships and team-building skills, working with both technical and business units
Test Data Management Tools
Various scripting and coding languages such as Python, Ruby, Javascript
Skilled Testing Principles – Rapid Software Testing
Negotiation and Influencing skills
Problem solving, analytical thinker
Talent Management

Senior Manager, QA-commercial Parenteral Resume Examples & Samples

Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls ensuring that performance and quality of bulk drug substance and parenteral drug products conform to established standards and regulatory agency requirements
Working directly with operating entities (internal and CMOs) to ensure that commercial bulk drug substance and parenteral drug product operations remain in a compliant state, and product meets all required standards and specifications; specifically, managing commercial change control, lot disposition, quality investigations and CAPA resolution for aseptic products
Leading external commercial quality audits; hosting internal audits by license partners, and representing Gilead during CMO site inspections by regulatory agencies
Create, review and/or review and approve standard operating procedures to ensure alignment with practices
Key strategic member of Quality Assurance management team in continually assessing quality systems, providing guidance and direction for improvement and implementation of efficiencies
Ability to work collaboratively with commercial and development product manufacturing teams, business partners and CMOs
Strong working knowledge and application of 21 CFR parts 11, 210, 211, 600, 601 and 610; EU Annex 1 and other applicable regulations and guidance documents); experience with medical device regulations 21 CFR part 820 and ISO requirements for combination productions under section 13485 is desired
Commercial experience with biologics bulk drug substance manufacturing and aseptic fill/finish
Demonstrated comprehension of aseptic practices, engineering controls, cleaning/sterilization processes, and process microbiology
Previous experience with outsourced manufacturing operations and required oversight, communication and partnership
Proven leadership skills in a fast-paced, team of varying skill levels and expertise
Experience in release of Commercial parenteral products into a global supply chain
Desire to work with department management to facilitate team growth and technical advancement
Effective communicator at both a tactical and strategic level
Some domestic and international travel may be required, estimated 20%
8+ years of relevant experience and a MS

Manager / Senior Manager, QA Resume Examples & Samples

Maintain a state of inspection readiness for developmental products
Support routine operations and allocate assigned resources
Manage competing priorities
Review and approve investigation reports, deviation reports, and CAPAs as assigned
Serve as the Quality representative on cross-functional and multi-site teams as assigned
Identify, design, and implement process and system improvements
Serve as a Quality subject matter expert (SME) in support of department functions
Supervise and assign new projects to Sr. Quality Specialists/Quality Specialists
Review and approve controlled documents relating to Quality involvement in the execution and phase appropriate control of clinical development studies
Participate in inspection preparation activities
Participate in deviation investigations and ensure deviations are thoroughly identified, defined and properly assessed
Interact with interdepartmental contacts on deviation assessment, resolution, and quality approval
Ensure that the proper policies and procedures are in place

Senior Manager, QA-pos / Stores IT Resume Examples & Samples

Spearhead key initiatives in the transformation of imbedding quality in the project lifecycle and achieving a higher level of skills, processes and results
Oversee planning, scheduling, tracking and results for all testing that impacts store operations
Partner with development teams to align Testing CoE (TCOE) engagement model with business needs
Manage financial forecasting and variance explanations for TCOE on all project engagements
Collaborate with peer managers (onsite and offshore) to ensure test execution is effectively and efficiently accomplished
Own creation and management of project estimates, ensuring all engagements and partner teams are considered
Ensure process standards are defined and complied with to ensure consistent results to the business
Manage by metrics to drive desired behaviors and results within TCOE and with development teams
Excellent communication (both oral and written) and partnering skills
Strong collaboration skills with onsite/offshore model
10+ years’ direct people management (Hiring, Terminations, Appraisals, Salaries)
10+ years’ project/program management experience in (waterfall/SDLC and iterative/agile methodologies)
8+ years’ experience in supporting retail store technologies and environments (including POS)
Proficient in use of HP ALM (Quality Center) Defect Management
2+ years’ experience in Continuous Build/Continuous Integration development environment
Knowledge of MS C# Stack (testing and/or development)
Experience with POS hardware, software and mobile devices used in retail operations
Adept analytic skills for problem solving
Bachelor’s Degree in Computer Science/Engineering nice to have

Senior Manager, QA Resume Examples & Samples

Recognize, exemplify and adhere to ICON's values which centres around our commitment to People, Clients and Performance
Effectively implement and maintain Clinical Quality Assurance procedures and processes in adherence with ICON SOPs. ICH GCP, GVP and appropriate regulations
Ensure all necessary training is provided to auditors to improve their job performance and knowledge. Provide coaching/mentoring and a benchmark of auditing competencies, as necessary
Acts as the key business contact representing QA in promoting QA services & capabilities. Liaises across QA functions and other QA Business Partners / QA Alliance Managers, as required
Provides strategic-level GVP & GCP compliance consulting advice, support and guidance
Develops and manages internal departmental audit programme in conjunction with Operational Management
Communicates decisions, priorities and relevant quality & compliance information
EU/AsiaPac: in depth proven experience in a quality/regulatory pharmacovigilance compliance position, with a proven track record of success in managing quality projects and teams with broad quality assurance experience
In depth knowledge and understanding of drug development, clinical trial and drug safety processes
Thorough knowledge of current regulatory and ICH GCP and GVP requirements and experience with global regulations and guidelines including post-marketing pharmacovigilance
A satisfactory progression of auditing experience with experience in leadership and QA management
Highly developed problem solving skills and the ability to resolve difficult conflicts
Team building and leadership skills
Strong people management and communication skills with the ability to Influence others and gain commitment
Demonstrated training skills, including the ability to give constructive feedback
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Drivers license
University/Bachelors Degree or local equivalent in medicine, science or equivalent degree/experience
Higher degree (MSc or PhD In life science medicine, or related field) would be an asset
LI-HD1

Senior Manager, QA Resume Examples & Samples

Identifies resource needs and facilitates procurement of resources, resolution of resource conflicts, and business justifications and/or trade-offs related to resource utilization
Builds effective, cross-functional teams that accomplish sustaining supporting and project objectives on a prescribed schedule and with a prescribed budget
Grows talent within the organization by leading employee development initiatives
Participates in the definition of area goals and drives teams to deliver on goals
Leads organizational management of a team of dedicated Quality Specialists and Quality Engineers for consumable product manufacturing, testing, release and distribution activities
Drives continuous improvement initiatives to advance quality processes and capabilities
Advocates strategically and operationally effective solutions to complex problems
Contributes quality and compliance expertise and guidance to teams responsible for addressing specific quality issues
Establishes and monitors process metrics and develop action plans as needed
Works with business process owners to identify and implement solutions to track and action quality KPIs
Reviews non-conformance and CAPA reports. Tracks program health for the San Diego site
Quality SME for site validation activities
Leads or provides subject matter expertise during internal and external quality system audits
Leads or represents functional area in Management Review and Quality Review processes
Leads or represents functional area in material review board and CAPA review board
Provides management with plans and status updates on assigned responsibilities and goals and escalates issues in a timely fashion
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; Establishes and supports best practices for problem solving, root cause analysis, and solution selection tools
Acts as a delegate for the Quality Assurance site lead

Senior Manager, QA Commercial Product Resume Examples & Samples

Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls ensuring that performance and quality of drug products conform to established standards and regulatory agency requirements
Providing expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance
Working directly with operating entities (internal and CMOs) to ensure that commercial drug product operations remain in a compliant state, and product meets all required standards and specifications; specifically, managing commercial change control, lot disposition, quality investigations and CAPA resolution for solid dose products
Participate in external commercial quality audits; hosting internal audits by license partners, and representing Gilead during CMO site inspections by regulatory agencies
Draft, and/or review and approve Annual Quality Reviews and regulatory submissions
Managing and mentoring a Quality Assurance staff of 2-4 Quality Assurance individuals
Manages QA personnel, including organizing and prioritizing group tasks, performing training, and writing performance reviews. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements
Participates in developing Standard Operating Procedures to ensure quality across internal and CMO operations
Maintains Quality Assurance programs, policies, processes, procedures and controls ensuring that
Performance and quality of products conform to established standards and agency guidelines. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications
Leads compliance audits as required
Interfaces with contract manufacturers to address documentation and compliance issues
Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
10+ years of relevant experience in a GMP environment related field and a Bachelor’s degree in science or related fields

Senior Manager QA Manufacturing Resume Examples & Samples

Ability to develop self and others
Effective time management and prioritization skills
Commitment to Hershey Leadership Behaviors
Problem solving/decision making abilities
Knowledge of and commitment to assuring regulatory compliance
Knowledge of quality assurance and quality control principles
Knowledge of safety assurance principles and practices including safety regulations
Minimum 5 years of leadership/management experience (with direct reports) required
Minimum 8 years of manufacturing experience in a high speed automated Consumer Goods environment required (e.g. production of food, pharmaceuticals, household goods, tobacco)
Minimum 5 years of experience with progressive responsibility in Quality Assurance required

Senior Manager, QA Compliance Resume Examples & Samples

Provide effective personnel leadership including: selecting key personnel and motivating members of the functional area; assisting with Performance Calibration/Talent Pool Management; individual goal setting/performance reviews; managing the development of employees, training and development; supporting team activities and Transition Workshops; supporting workforce diversity, quality and safety and supporting supervisors/managers in individual/department/business objectives
Identify and evaluate issues of significance, communicate complex issues to quality leadership, provide multiple alternatives to the solution of complex problems and the ability to provide guidance in their implementation
Provide site management for Quality Management Review (QMR) program. Ensures that all relevant data is presented to Site Leadership. Provides appropriate metrics and trending analyses
Manages non-routine projects of moderate to high complexity, using resources across site and across departments to assure timely remediation of high quality. Leads teams to provide highly scientific evaluation of issues intended to mitigate business and compliance risk while maintaining product supply
Provides effective leadership in training and developing internal customers/stakeholders on compliance topics. Provides leadership to motivate members of the functional areas, in support of workforce quality, safety and compliance
Provide quality/compliance guidance to internal and external business partners. Manages the internal audit program. Ensures that audits are performed per developed schedule, reviews findings and makes recommendations for findings. Ensures timely response and closure of all action items / commitments
Ensure that the Quality Systems, GMP procedures comply with legal and regulatory requirements and are aligned with
Excellent people skills to convince, motivate and encourage customers/stakeholders to understand and accept his/her recommendations, especially with borderline issues
Proven ability to express views and opinions, listens well and accept conflicting points of view
The ability to independently recognize opportunities and the need for business and process improvements
The ability to self-motivate to a high level of productivity
Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities
In depth knowledge of GMP
The position requires broad knowledge of biotech/pharmaceutical product life cycle and manufacturing (e.g., product development, fermentation/cell culture operations, purification operations, fill/finish/packaging, distribution, validation)
Advanced technical writing abilities including advanced knowledge of word processing software functions and capabilities (e.g., MS Word)
Familiarity with change control processes for regulated industries
Participation and/or support of pharmaceutical regulatory inspections
An advanced degree is preferred

Senior Manager, QA Engineering & Validation Resume Examples & Samples

Provide quality oversight, lead and support complex deviations, CAPA, and change controls related to process unit operations, critical utility and facility systems
Assess on an on-going basis the changing regulatory environment to establish policy, procedures and processes that drive continued cGMP compliance and business success
Success is measured by projects that are implemented compliant with regulations and that have been executed to meet all regulatory expectations in the disciplines of process engineering, automation, and facility/utility systems. Provide QA leadership and oversight to equipment lifecycle process activities including commissioning, requirements identification, equipment impact and criticality assessments, design review, construction, calibration and preventive maintenance
8 – 10 years specific Engineering, Validation & Quality Assurance experience working within a biotech organization; Thorough GMP knowledge a must
Mastery of the entire engineering design field and broad knowledge of biotech facility design /process requirements
Understanding of facility infrastructure requirements including utilities, environmental control systems and maintenance
Ability to apply fundamental engineering principles to resolve issues relating to utilities, process equipment, process automation, CIP & SIP design, and facility/system design
Deep knowledge of commissioning, qualification and validation requirements for clinical and commercial biopharma facilities. Fluent in risk based approach using ASTM E2500 approach
Proven experience in establishing a Plant QA Engineering Operations function for the approval of batch records, work orders, deviations, CAPA’s and Change Controls in an efficient and sound process
Expertise in applying quality principles to manufacturing, facilities & engineering and laboratory testing for the manufacturing of biopharm products
Experience in applying quality principles to manufacturing, facilities & engineering and laboratory testing for the manufacture of biopharm products
Demonstrated management skills in developing, motivating, and organizing high performance work groups in the biotechnology industry
Excellent communication skills – both upwards and downwards and outside of company. Ability to lead and communicate orally, in written documents, and in formal presentations required

Senior Manager, QA & Integration Resume Examples & Samples

Detects failures, gaps in order for defects to be discovered and corrected with minimal impact and/or risk to the organization
Records and documents incidents in order to determine solutions
Prepares planning material to address defects and collaborates with key stakeholders to execute and measure
Ensures all areas of the business adhere to the best practices of quality controls, checks and balances applicable to the operational function
Determine and understand fully the active projects, processes in order to ensure quality integration is managed effectively. Drives roadmap initiatives and delivers on strategy
Leads meetings across the organization with all levels of management to effectively communicate status of situational events that could lead to risk, reputational or other
Develops/tracks scorecard across processes in order to record and understand defects and correct the action
Bachelor's degree in Business or Operations Management
Certifications: Quality auditing, quality improvement associate, Six Sigma
10+ years of quality inspection, experience with corrective action programs, knowledge of tools, concepts and methodologies of QA, knowledge of regulatory requirements
3 to 4 years of supervisory experience
Data collection and management of information with detailed reports
Plans and organizes
Implementation of plans
Navigate and develop paths through ambiguous situations
Ability to multi task

Senior Manager, QA, Software Engineering Resume Examples & Samples

Maintains awareness of business, technical, operational, architecture and infrastructure issues
Device applications
Testing automation
Networks and Network hardware (including customer CPE)
Applications programming/analysis

Senior Manager QA for R & D Research & Pre-clinical Resume Examples & Samples

Ph D or University (Master) degree in Sciences: Biology, Chemistry, pharmacy, Bio-engineer
At least 10 years in Pharmaceutical company covering various R&D areas: Research, Pre-Clinical, Clinical Labs, Animal Testing
Strong QA Experience in an FDA/EU regulated environment
Executive and leadership capability to manage people
Deep knowledge in quality regulation requirements covering GLP, GSP, GxP and general quality compliance such as data integrity
Strong knowledge of animal testing
Strong sero-toxicology, clinical trials and laboratory process knowledge
In depth knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation)
Good knowledge of quality and risk management principles and tools
Good knowledge of French and English (spoken and written), Italian is a plus
Ability to lead, influence and convince people in a complex organization
Ability to manage networks and build relationships transversally across the Vaccines network
Flexible thinking
Ability to adapt, work under uncertainty and accommodate flexible work demands
Global perspective; cultural sensitivity
Develop, assure and maintain the quality of the vaccine research and pre-clinical testing processes
Standard procedures (worldwide regulatory requirements)
Research and Development Quality
Control the quality and accuracy of the data used in drug discovery
Guarantee that the R&D studies (discovery, preclinical, early clinical) are performed in accordance with Good Scientific Practices (GSP), GLP, local, corporate and international regulations
Define quality audit programs and follow-up on their implementation
Organize and take the responsibility for Quality Assurance in Research & Pre-Clinical activities for R&D Department
Establish SOP’s for quality standard in collaboration with other departments and based on Global Quality Assurance and or corporate policies
Make sure that the records, SOP’s and documentation have been completed and endorsed by the staff authorized to do so
Approve master records, procedures, validation protocols, results and conclusions
Make sure that any deviations, OOS, changes have been authorized by the persons responsible in accordance with procedures
If relevant, assure final approval in method validation
Ensure inspection readiness and CAPA follow-up
In collaboration with audit team, prepare, participate to and assure regulatory inspections,
Make sure that Business Monitoring (self-inspection) are performed,
Assure internal self-inspection for his/her team,
Make sure that commitments are followed up and implemented
Prepare and support the R&D Center for the audits run by GSK Corporate (L3 audit) and/or by external Health Authorities (L4 Audit)
Optimize and maintain the compliance level of the quality systems with Quality System and Services (QSS), regulatory, GSK corporate and GSK Vaccine standards in R&D Center
Ensure a consistent approach to the interpretation and implementation of GSP/GLP standards
Responsible for coaching, training, motivating and evaluating his/her direct reports through effective performance KPI’s
Provide QA expertise and support to related teams
Responsible to ensure that standards GSK requirements in terms of research & pre-clinical activities are in line with authorities requirements within all laboratories internally to GSK worldwide and out-contracted by GSK (in collaboration with Third Party Oversight representative
Manage the QA R&D Research & Pre-Clinical team to ensure the compliance of the R&D Operations with GSK requirements

Senior Manager, QA, External Manufacturing Resume Examples & Samples

Ensure regulatory and contractual compliance following applicable standards including FDA regulations, American Association of Tissue Banks (AATB) requirements, ISO 9001, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards
Conduct risk assessment and develop mitigation strategies as they relate to QA, QC, and RA people, process, and systems including organizational assessments; such as change readiness and develop training strategy to address gaps and needs
Provide leadership for preparation and execution of FDA inspections, AATB audits, ISO certification and customer audits by mentoring management representatives and verifying site readiness
Lead, participate, and mentor site personnel in investigations, complaints, CAPA, change control, auditing, document management systems, and process design and implementation
Provide guidance in the development and implementation of quality documents including SOPs, test methods, specifications, donor records, stability protocols, validation protocols, and batch record documentation; and review and approve quality documents and agreements with critical suppliers and partners
Lead and participate in Quality Assurance initiatives within cross-functional teams as a recognized expert and resource in one or more relevant non-project specific areas of expertise for the company
Demonstrate innovation in the project management and creation of deliverables and manage multiple projects simultaneously; work directly with other functional groups to ensure the inclusion of diverse, cross-functional perspectives into strategies and tactics that consistently enhance Quality Assurance's ability to deliver
Work with Integra senior division Quality Assurance management to set up EMQA , tissue/product QA programs for full execution
Coordinate and execute audits to qualify new and existing suppliers/contract manufacturers
Develop and manage the QE programs for MVP execution, pFMEAs, risk management and statistical support to QA
Control and approve all changes to product /process specifications for products supplied by supplier/contract manufacturers
Establish and implement DHR review and final lot approval of product from supplier/contract manufacturers, including donor record reviews
Prepare and execute Quality Agreements for the daily interactions and sharing of responsibility between the QA departments at Integra and supplier/contract manufacturers
Design and execute Quality Plans for projects to commercial new products and for product transfers
Establish procedures for the execution of the Quality Assurance program
Lead and chair EM change control, MRB and CAPA boards
Develop and report key metrics to manage and evaluate control of the supplier/contract manufacturer QA programs
Develop and present EMQA key metrics to division and corporate QMR, SMT and EMT
Manage and track spending versus assigned budgets
Design and execute training programs for Integra QEs and supplier/contract manufacturers for the QA program

Senior Manager QA, Mammalian Operations Resume Examples & Samples

Develop and lead Quality strategy for F10P10. Partner with area and site QA and Manufacturing leadership to ensure alignment in execution of the Quality strategy
Act as lead Quality SME for F10P10 issues and escalations. Escalate quality and compliance issues to Site Head of Quality
Ensure that Quality Systems in support of F10P10 meet Lonza Corporate standards and regulatory requirements
Build and maintain expertise in the F10P10 QA group
Partner with the customer on Quality strategy and execution. Serve on joint Lonza-customer teams
Manage and track KPI’s; develop and implement strategies to ensure that KPI targets are met
Experience in a GMP Environment with an emphasis on leading QA Teams
Experience in a Quality Leadership function, or an equivalent combination of education and experience
Experience in Quality Operations and Manufacturing within the biotechnology industry is a plus
Experience in batch record review, deviations, change controls, procedure review and approval
Experience in the disposition of products to multiple jurisdictions
Experience leading and/or supporting GMP Inspections by Health Authorities

Senior Manager, QA Operations Resume Examples & Samples

A range of experience in various Technical and Quality Assurance roles across multiple dosage forms
Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment
Good knowledge and demonstrated application of Quality and Risk Management principles and tools
Quality input into CMO dose form/category sourcing strategies, requiring global matrix leadership across respective Group Leaders
Running Quality Governance processes
Leading strategic improvement projects
Accountable for delivery of NPI within the Supplier Relation Team and is required to resolve technical and regulatory issues, supporting the Quality Managers when requiring advanced knowledge and experience
Run the Product Incident Recall Committees within designated CMO / product portfolio. Responsible for ensuring root cause analysis is performed and appropriate recall decisions proposed in line with GSK regulatory and quality expectations. The person in this role would be certified to lead PIRCs
Ensure there is appropriate communication, cascading of information, prompt escalation of significant issues or risks across the organization, driving prompt resolution of issues. Actively participate in GSK management review forums. Drive periodic review of quality systems at CMOs and lead Quality agenda in relevant Business Review meetings
Ensure that CMO facilities and systems meet and maintain current regulatory requirements & expectations and report all potential and actual cGMP/Regulatory compliance issues. Ensure approved Quality Agreements are in place for assigned CMOs
Ensure there is appropriate application of risk management by identifying potential short comings in supplier’s quality systems, considering the risk to patient safety and efficacy, product integrity, regulatory compliance and GSK business

Senior Manager QA Engineering Resume Examples & Samples

7 years of technical experience in a related discipline (e.g. Quality Engineering, Engineering, Manufacturing, Integration & Test)
5 years of experience managing or leading personnel. Minimum 3 years as a coded leader
Demonstrated knowledge and experience with nonconformance processing including root cause analysis and corrective action development
Working knowledge of AS9100, ISO9000, and AS9003 standards
Demonstrated Full Spectrum Leadership behaviors
Current Special Programs SCI access
Experience making Preliminary Review / Material Review Board decisions. Current MRB certification a plus
Current AS9100 auditor certification

Senior Manager QA, Compliance Resume Examples & Samples

To provide leadership, enablement and direction to the Compliance Quality Assurance team to ensure that the quality system is fulfilling the regulatory and business needs for the FCS UK site
To ensure absorption into the quality system of any future acquisitions in support of the global distribution business for FCS
To work via business development and Project Management to ensure that the FCS Quality Assurance function is engaged with customer to ensure that Quality is a service differentiation for FCS globally
Ensure the next generation of GXP systems are fully compliant with the relevant legislation
Quality performance monitoring and liaison to resolve quality issues
Extensive knowledge of GMP/GDP environments
Knowledge of the Clinical Manufacturing and QA compliance/Quality Systems process globally
Eligibility to become a Qualified Person would be desirable for this position
Teamwork especially in a matrix management organisation. Ability to influence across functions across Fisher sites and across companies to achieve objectives
Significant experience gained at a senior level within a pharmaceutical environment
Flexible and adaptable, with strong customer management skills. Must be highly responsive whilst maintaining strategic direction. Needs to be comfortable with ambiguity
Degree Level or Equivalent in relevant subject
Professional Qualifications within the quality arena

Senior Manager QA, Packaging Resume Examples & Samples

To provide leadership, enablement and direction to the Manufacturing and Packaging Quality Assurance team to ensure that the quality system is fulfilling the regulatory and business needs for the FCS UK site
To work via business development and Packaging Project Management to ensure that the FCS Quality Assurance function is engaged with customer to ensure that Quality is a service differentiation for FCS globally
Provision of quality consultancy advice to sponsors planning clinical programmes in Europe – e.g. small /medium Biopharma companies in the USA
Quality performance monitoring and liaison to resolve quality issues with Manufacturing and packaging environmentsa
Take part in Senior management meetings as required and to provide relevant information to the meeting including project updates and Key Performance Indicators to GM, Finance and Senior Management team
Working with the direct reports to ensure all Fisher activities come together in a timely manner – this could include supporting direct reports to overcome barriers to service delivery
To undertake additional duties as directed and agreed with the Director, Quality
Knowledge of the Clinical Manufacturing and packaging process globally
Proven networking skills – must be able to network internally and externally with client organisations and other service providers
Process analysis skill suitable to collect/analyse data leading to proposed process improvement with quantifiable business benefit
Ability to recruit and manage staff to achieve business objectives. Able to prioritise teams workload and to ensure others meet timescales
Able to analyse problems and define solutions
Able to work under pressure and to support others within the team
Good communication skills both internally and externally. Ability to understand the clients requirements and to be able to devise and articulate the most appropriate solutions
Creativity – ability to be confident and convincing at highest level within the client organizations
Business management training – especially in business processes analysis/process improvement

Senior Manager QA Value Stream Resume Examples & Samples

Lead a team of direct and indirect reports to meet the quality needs of the value stream within the plant operations and laboratory finished product testing
Ensure operations are compliant with internal GSK standards (local and global procedures) and health authority expectations; in addition, ensure processes are efficient without compromise to quality of the finished product
Oversight of the quality operations in production areas as well as the finished product testing laboratory
Liaise with the business partners and ensure cooperation and support with regards to efficiency programs within the value streams
Manage a matrix organization with the indirect team of associates for QA release, product complaints, supplier management support, regulatory compliance, and product quality review to ensure the QA value stream team is aligned behind common objectives
Appropriately manage escalations within the value stream to ensure compliant and timely resolution
Ensure engagement within the value stream and with the supporting quality systems and standards organization for definition and adherence to key performance measures within the scope of the value stream
Ensure adequate assessment and timely closure of deviation events within production and laboratory operations – provide team support where needed
Advanced degree in Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific
Degree.10+ years’ experience in a Pharmaceutical Environment, with at least 5 years in management position
Proven process understanding (Pharma, GMP, investigation and method development)
Direct experience with production operations and laboratory activities
Experience with Manufacturing Site needs and constraints.Safety, Quality, Result and Customer oriented
Well organized, pragmatic and able to define and support Strategy
Excellent Communication skills, in English and French

Senior Manager QA Delivery Owner Resume Examples & Samples

Responsible for establishing and clearly communicating the overall test strategy to the QASS and Technology Leadership Team and aligned with key business initiatives that could consist of cloud computing, technology transformations, strategic architecture direction, and shift-left methodologies
In coordination with the QA COE the QA Delivery Owner is responsible for establishing the strategy that may consist of, but not limited to, data management and refresh schedule, production staging environments, alpha and production checkout nodes, test system integration with up-line and down line code and system configurations including customer test systems, continuous integration and continuous deployment support, end-2-end testing and monitoring and cloud implementations, cross LOB integration efforts, and cloud based tools
Responsible for ensuring the Team is well-versed in the test strategy and can clearly communicate and execute on it
Directs team to actively and frequently engage with key stakeholders across the LoB’S including Architecture, Development and Delivery Manager to assess test environment issues and initiate, track and prioritize remediation activity
Directs the team to engage with the Infrastructure Test System Support team to assist in identification and remediation of test system issues that are impacting the delivery of product
Directs team in proper root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements for the team
Manages the balance of resources required to support the constant changing project work flow that consist of direct hire employees, onshore and offshore contracting resources, fixed-bid, time and material, and managed services agreements
Directs the team in establishing close relations and engaging early with the project teams so that they can assist the team in the buildout, maintenance and integration of their test tools and data plan
Strong business leader with a Degree in IT engineering or computing science

Senior Manager, QA Operations Resume Examples & Samples

5+ years working knowledge of QA Operations disciplines including Receiving and Final Acceptance (DHRs) and Control of Nonconforming Product (QNs, Returns, Product and Market Holds)
Experience with Risk Management regulations and application (ISO14971)
Experience with equipment controls (CAL/PM)
MS Office proficiency is required, specifically Excel and Word
Experience in personnel management and/or team leadership
Demonstrated ability to develop and lead process implementation and improvement in a team environment
Experience with CAPA processes including investigational techniques
Working knowledge of production and process controls
Strong technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation)
Ability to influence positive change effectively. Exceptional conflict-resolution skills

Senior Manager QA / FvP Resume Examples & Samples

Supervises the pharmaceutical business of BGP Products GmbH in Switzerland as FvP and ensures that only medicinal products are released onto the market that meet the specifications in force and are produced in accordance with Good Manufacturing Practice (GMP)
Ensures that a local Quality Management System is available, ensures that medicinal products are stored and handled appropriately, ensures that medicinal products are distributed in accordance with the rules of Good Distribution Practice (GDP) and ensures that manufacturers of imported medicinal products hold a valid GMP license
Keeps the daily business running which includes e.g. market release, PQRs review, deviation / complaint / recall handling, supplier qualification including technical agreements, etc
Necessary qualification as a FvP according to HMG and AMBV and also for controlled substances according to BetmKV Art. 12
Strong experience in Quality Assurance in the Pharmaceutical industry (i.e. in depth knowledge of GDP)
Direct experience to act as contact person for all quality-related issues for BGP Products GmbH’s with Swissmedic, Cantonal Authorities and TPMs
Able to rapidly adapt to changing environment and circumstances requiring flexibility and tolerance while assuring that all regulatory requirements are met
Experience with SAP, Trackwise, Documentum are a plus
The individual should be a person of integrity

Senior Manager, QA Automation Resume Examples & Samples

Work with the team to create a fault tolerant and robust testing automation framework that can be used to continuously validate the quality of our software
Evaluate current automation practices and techniques to ensure best of breed automation techniques are being utilized and make adjustments where necessary
Implement information radiators to make automation test results accessible by the entire organization
Work with manual test to design and implement a cohesive testing strategy
Experience in developing browser based automation tests using frameworks like Selenium within continuous integration environments
Experience with system scalability testing and load performance testing by using tools like jMeter
Experience testing web services
Software test and/or engineering experience, including but not limited to

Senior Manager QA Change Control & Document Control Resume Examples & Samples

Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and for change control and multi-product approaches utilized at BioMarin
Critically evaluate change control and associated documentation - provide technical and Quality input ensuring adherence to GxP and BioMarin requirements
Represent Quality Assurance in multi-department meetings and project teams
Develop and report on system metrics
Provide QA oversight of manufacturing product changeover and shutdown activities
Represent systems during audits and regulatory inspections
Proven track record of leadership, technical, management, problem solving, and project management skills
Organizational and management skills to handle multiple functional groups, with the ability to effectively delegate work
Ability to comprehend technical information related to equipment, processes, and regulatory expectations
10+ years of experience in a GMP regulated environment, with exhibited knowledge and proficiency of quality systems (Change Control/Document Control preferred)
4+ years of experience in a management or supervisory position
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for departmental functions (understanding of regulatory guidelines for other countries a plus)
Experience in participating in regulatory inspections, presenting/defending departmental functions in audits or regulatory inspections (specific experience in defending quality systems preferred, but not required)
Experience and proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point
Experience with TrackWise Quality Management System preferred
Experience with one or more Electronic Document Management Systems (EDMS) preferred

Senior Manager, QA, Cloud Engineering Resume Examples & Samples

10+ years of product development or quality engineering experience
5+ years of experience leading a team of QA engineers through a product cycle
3+ years of experience testing cloud based technologies
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Senior Manager QA Operations Resume Examples & Samples

BSc/BEng in a Science or Engineering discipline and at least 8 years experience; OR Masters or PhD and at least 6 years experience; AND/OR equivalency in education and experience
Prior experience auditing either external or internal groups
Change Management experience
Operational Excellence exposure
Line Management experience desirable
Lead the Product Incident Review Committee (PIRC) within the allocated dose form/category cluster
Lead directly a group of Quality Managers who manage the interface and performance of CMOs over which GSK does not have direct control. This requires a high focus on influencing, building good relationships with key individuals, handling well pressure and recoursing to contractual requirements when necessary
Ensure there are investigations into significant quality incidents arising at suppliers and ensure root cause of the problem is identified and appropriate corrective and preventative actions are implemented
Implement Quality Systems performance management with appropriate Key Performance Indicators. Track and provide supplier performance feedback to drive continuous improvement through the team of Quality Managers
Provide quality input to ensure sourcing strategies are appropriately defined and implemented over time frames of 2-5 years
Review and respond to CMO regulatory inspections on matters that involve activities related to GSK products. Assess impact of inspection and External Supplier responses to Regulatory observations prior to submission to associated agency

Senior Manager, QA & Testing, Mobile Resume Examples & Samples

Manage End to End quality control process & deliver testing solutions across a complex wireless provisioning eco system
Management of departmental resources, staffing & mentoring to maintain a best in class and high performing quality engineering team
Implement performance metrics and prepare periodic reports. Monitor and track project progress and report findings to leadership team
Design and Develop quality roadmaps to help drive the transition to a NextGen billing and provisioning platform
Partner closely with technology, product & architecture to develop the best technical solutions that provide an excellent customer experience as well as drive operational efficiency
Manage and execute against project plans and delivery commitments of the department
Monitor technical and engineering progress to ensure strategies, goals, and objectives are met. Align operational plans with business objectives
Provide complexity and cost estimation. Develop case studies, roadmaps and models to influence strategic spending
Influence design & development strategies. Contributes to software design & architecture reviews
Develop prototype solutions and simulation models to prove out technology directions
Communicate changes to all stakeholders. Provide leadership and direction for team which may include multiple functional areas
Regular, consistent and punctual attendance. Must be able to work nights and weekends, variable schedule(s) as necessary
Strong business & technical vision

Senior Manager QA Belgium Engineering Resume Examples & Samples

University (Master) Degree in Sciences / Biological Engineering: Mechanical, bio-engineering, electro-mechanics
Minimum 10 years of experience in Manufacturing, QA or Engineering within a GxP environment
Direct experience with GxP regulated environment within major authority jurisdiction (FDA/EU/WHO Audit)
Previous experience in a similar function in other industry (Petrochemical, Food, Consumer, Automotive…)
Need to master the key QA activities related to production, QC, maintenance, calibration, and validation in his/her area of responsibility
Achieve quality performance targets, regulatory compliance and cost efficiency for the teams for Belgium, ensuring team objectives are aligned with the overall Quality, Belgium QA, GIO goals and objectives
The scope of the QA Be Engineering oversight includes
Approval of the Belgium Engineering SOPs and guidelines as well as in use/in place quality oversight,
Supporting change control approach dealing with CAPEX projects on the Belgium sites
Providing Quality support for all calibration and industrial maintenance activities related to CAPEX project and Start-up activities
Ensuring GIO/Quality Be standards are applied and followed during all phases of projects to ensure smooth handover with the business (this may include, but not limited to : spare parts requirements, change control processes, master data, maintenance plans, etc)
Standing at Be Engineering Governance meeting as QA representative for the Belgium QA Organization
Ensuring Belgium Engineering service providers and suppliers are well managed in terms of Quality agreements and eventually in terms of audits for any activities performed on site or not
Ensuring the Belgium Engineering organization is compliant to all applicable Quality Systems
QA lead roles for major site remediation plan (FDA remediation plan, Rixensart remediation program (D-Rix) and reliability improvement program on industrial facilities and utilities (MSRG))
QA Validation roles to support the expected validation phases to Engineering projects and deliverables but also to bring guidance and advice for preliminary phases (commissioning) to anticipate the handover steps
The purpose of the function is to ensure that all the quality requirements applicable for the above listed activities are in place and in use across Belgian GSK Vaccines sites that includes 13 Manufacturing units (MPU) and 3 Support Units (SPU)
This job includes the management of resources and budget related to a cost center to achieve the strategic objectives defined by Quality and operational departments
This job includes ability to evaluate potential consequences of risks identified on patient safety and regulatory aspects (escalation and communication)
This position aims at translating QA management decisions and requirement in field of actions with the help of the dedicated teams and network (within sphere of influence)
Drive a continuous Quality and Compliance improvement mindset within the department to ensure compliance with cGMP’s and GSK Quality Management System
Maintain knowledge and experience up to date in the light of technical, scientific and regulatory progress, trends and changes in quality management
Drive a continuous Quality and Compliance improvement mindset in his/her organization and in the organization of his/her operation partners to ensure compliance with cGMP's and GSK Quality Management System
Be the compliance authority for major CAPA having the potential to affect the business site wide
Be the SPOC QA for Engineering related subjects under his/her scope of responsibility, act as QMS SME (knowledgeable of the QMS standard related to the area of expertise, ensure all requirements of the standards are cascaded in SOP's, accountable for gap analysis and related action plans). And as a consequence, be the preferred front line spokesperson as QA during inspection to present and defend key deliverables from own scope of responsibilities and by supporting the business process owners
Leads local and transversal QA improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirements, performs internal audits and could act as auditor for external supplier and service providers
Understand technical/manufacturing and systems complex problems and evaluates potential impact on product quality, assess quality reviews files and draw adequate conclusions
Assures and develops the quality of his/her operation partners in the frame of his/her activities
Prepares audits (L2,L3 and L4)
Follow up of CAPAs (L2,L3 and L4)
SOPs : approves and promotes improvements
Documentation : assure compliance
Deviation : approve and investigates / coordinates critical one in link with this activity
Manages budget and resources allocations

Senior Manager, QA Resume Examples & Samples

Create test and release plans and their execution before and during software deployment
Perform and coordinate regular regression tests on various application software
Communicate with multiple groups (business and technology) for coordination and execution of test scripts
Provide guidance and mentoring to the testing team, members of which may not have a reporting relationship to this position
Participate in the testing and quality assurance of software produced by software vendors and internal application development team
Lead preparation and executes test cases: ensure software operates as designed and is compliant with software requirements
Document and reports test results
Concisely track and report software defects
Interface with IT personnel as well as business partners for the remediation of software defects
Assist in the preparation of software deployment
Responsible for software readiness sign-off
Periodically provide production support