Quality Assurance Senior Manager Resume Samples

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M Kulas

Michale

Kulas

24791 Tyree Neck

Detroit

+1 (555) 910 6276

24791 Tyree Neck

Detroit

Phone

p +1 (555) 910 6276

Experience Experience

San Francisco, CA

Quality Assurance Senior Manager

San Francisco, CA

Murazik-Waters

San Francisco, CA

Quality Assurance Senior Manager

Training, coaching and mentoring team members to achieve their potential
Provides or assists on employee training to ensure compliance with procedures and regulations
In-depth knowledge of third-party GMP auditing schemes and GFSI standards
Develops training and related reward systems
Technical and working knowledge of quality assurance principles, processes and techniques
Develops systematic approaches for assuring high quality services
Knowledge of manufacturing plants and sanitation practices across multiple CPG industries

Chicago, IL

Senior Manager of Quality Assurance

Chicago, IL

Beahan and Sons

Chicago, IL

Senior Manager of Quality Assurance

Develop, implement, manage, audit, and maintain Quality Systems (GXP compliant) for development and commercial activities at a specialty pharmaceutical firm
Provide monthly metrics to VP of Global Quality Assurance and Senior Management in Asia
Manage compendia changes
Manage and evaluate change controls
Troubleshoot issues in the manufacturing and packaging process and perform CAPAs as necessary
Head continuous improvement through good communication with all departments involved
Guide QMS Data Collection Analysis and Improvements

present

Chicago, IL

Senior Manager, Global Quality Assurance

Chicago, IL

Runolfsson, Hudson and Bartoletti

present

Chicago, IL

Senior Manager, Global Quality Assurance

present

Work with teams within the Global Quality Engineering organization to drive future-state vision and efficiencies with respect to test automation planning, development and execution
Review, resolve, and escalate quality-related issues
Lead a dedicated team of software development engineers in test (SDETs)
Manage key vendor relationships responsible for testing support functions
Provide analysis and review of automation frameworks and processes to be employed across online and mobile platforms
Estimate test efforts
Support defect management

Education Education

Bachelor’s Degree in Finance

Emory University

Bachelor’s Degree in Finance

Skills Skills

Proficient with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly
Capable of concurrently managing multiple projects and delivering quality and timely results
Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus
Ability to handle multiple tasks while ensuring timely and accurate completion
Ability to work independently
Demonstrated ability to work collaboratively with other teams
Strong process adherence experience
Ability to work independently and handle multiple tasks while ensuring timely and accurate completion
Demonstrated ability to manage both onshore and offshore resources
Knowledge of continuous improvement methodology including Lean and Six Sigma

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Credit Risk Quality Assurance Senior Manager Resume Examples & Samples

Assist with development of infrastructure for the new Quality Assurance team including; policy/desktop procedures, reporting, and a database to track analyst’s work actions
Assist with identifying qualified candidates to initially staff team and additional staff as team grows
Proactively manage the analysts on your team to ensure accurate/consistent/timely feedback is provided to first line business partners and Risk executive management
Serve as the primary contact with first line management to deliver Quality Assurance findings and consider any feedback they provide regarding those findings
Work closely with Quality Assurance Director and other members of the Risk management team to ensure analysts efforts are focused on reviewing the most appropriate credit approval/declines
Assist with the development of a process to formally track identified issues and the status of their resolution
Establish goals for analysts and monitor their performance. Ensure they receive periodic performance feedback as appropriate
Manage on-going weekly team application review meetings to ensure the consistency and quality of feedback is maintained
10+ years of financial industry experience
Experience building new testing functions
Experience in driving technical solutions to meet testing and reporting needs
Experience building Key Risk Indicators and Key Control Indicators

Senior Manager Risk Data Quality & Assurance Resume Examples & Samples

Support all activities for the “Retail Credit Risk Roadmap Program (RCRRP)” and “Risk Data Aggregation and Risk Reporting (RDARR) Program”
Execute data management activities such as
Good knowledge of the retail credit business and risk management techniques
Good knowledge of retail credit products, policies, portfolios and delivery systems
A broad range of cross-functional business, industry and functional knowledge is required to integrate technical solutions with business requirements
A strong knowledge of the Bank’s platform applications
Industry knowledge of trends and best practices
Must be accurate and details oriented

Senior Manager, Global Quality Assurance Resume Examples & Samples

Work with teams within the Global Quality Engineering organization to drive future-state vision and efficiencies with respect to test automation planning, development and execution
Develop, review and signoff on strategic deliverables that advance GQE goals and objectives
Review, resolve, and escalate quality-related issues
Ensure quality processes are being appropriated leveraged at all levels in the organization
Lead a dedicated team of software development engineers in test (SDETs)
Manage key vendor relationships responsible for testing support functions
Provide analysis and review of automation frameworks and processes to be employed across online and mobile platforms
Estimate test efforts
Research, recommend, and oversee tools and technologies that support GQE processes
5-7 years of experience (minimum) in overall test management
Several years’ experience leading direct employees, departments, and vendors
Experience managing complex vendor relationships (in a multi-vendor environment) is strongly desired
Working knowledge of functional testing tools including HP ALM, Selenium, Jira, and Appium
Experience working within an Agile environment is preferred
Experience in managing embedded studio testing methods (SDET)
Willingness to travel up to 25% to other domestic Walt Disney Parks and Resorts locations

Quality Assurance Senior Manager Resume Examples & Samples

Support all staff in Quality Control/ Quality Assurance to ensure ongoing compliance
Manage and support remote Quality Assurance team
Training, coaching and mentoring team members to achieve their potential
Provide input on performance reviews for all staff within the functional area supervised
Manage Continuous Improvement Activities: Drive functional strategy, the creation, update and consolidation of necessary SOPs, change control and collection of data or measurement of critical compliance values as part of the Fisher BioServices continuous improvement plan
Responsible for implementation and execution of BioServices QA Plan
Trend and provide QA metrics to detect any recurring quality issues
Review Operational and validation records such as validations, calibrations, and reports as necessary
Ensure that quality documents, protocols, methods, material records are current, accurate and properly utilized
Conduct document review for both Commercial and Government operations
Review and approve BioServices change controls
Management of supplier/vendor program
Conduct supplier/vendor audits
Management of training program
Management of mock recall process
Conduct Management Review as applicable
Performs other duties as assigned by his/her supervisor
A minimum of 3-5 years of supervisory experience in a GMP or similarly regulated facility
A minimum of 3-5 years cGMP hands-on experience in Quality
Knowledge of software compliance (21CFR; Part 11)
Proficient with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly
Bachelor's Degree in Scientific/Technical field or equivalent
3-5 years cGMP experience
Ability to work independently and handle multiple tasks while ensuring timely and accurate completion
IND-CCG

Quality Assurance Senior Manager Life Sciences Resume Examples & Samples

Experienced Quality Leader drives the center of excellence for GMP reagents and complex detection reagents
Manages a mix of ISO 9001, ISO 13485 and cGMP Quality activities from monitoring and acceptance of incoming raw materials through final production release, assuring compliance to corporate and industry standards
Manages the site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, R&D transfers, and manufacturing area support
Responsible for the continued development GMP capability and maintenance of compliance to US FDA Quality System Regulations (QSR, Part 820)
Ensures effective transfers of new products into production that meet all the Quality requirements for the classification and intended use
Coordinates the development of action plans when corrective steps (CAPA) are required and implements these through the site steering team. Responsible for routinely managing, tracking and reporting Critical Success Factor metrics to support plant Quality initiatives
Ensures site wide training is effective and that the plant operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective
Interacts with customers, suppliers and regulatory bodies including hosting of audits and managing inspections
Performs as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation)
An the GMP center of excellence – assist in overall GMP strategy, best practices, and guidance across multiple GMP sites across the globe
Experience with Class III Medical Devices
Bachelor’s degree in biotech, science or engineering from accredited college/university or AA plus equivalent experience
Minimum of 8+ years related experience in Medical Device or Pharmaceutical Industry including 2+ years in a supervisory or managerial position
Experience hosting FDA inspections with successful outcomes
Knowledge of the pharmaceutical GMP regulations and their appropriate application is needed to assure compliance with regards to manufacturing problems

Quality Assurance Senior Manager Resume Examples & Samples

Assists with and follows-up on non-conformances, investigations, complaints, etc. Assures that issues are resolved in a timely manner and corrective actions are implemented and monitor effectiveness to prevent recurrence
Extensively interacts with Distribution Center and Customer Channels Group (CCG) headquarters personnel
Escalates quality events (as necessary) to Sr. Global Quality Leader and works with personnel to periodically review significant aspects of operations related to quality
Quality sponsor and interacts with customers on quality issues and is an advocate on the company’s quality concept
Ensures the continuing review of the QA program and the creation of new or revised procedures to effect improvements
Provides or assists on employee training to ensure compliance with procedures and regulations
Supports and assists on internal, regulatory and customer audits
Conducts all activities in a safe and efficient manner
5+ years experience working in an ISO (9001 or 13485 preferred) and/or FDA current Good Manufacturing Practices (cGMP) environment
5+ years experience in a regulatory, quality assurance/control environment
Ability to travel and work in a laboratory, warehouse or manufacturing environment
Experience with Quality Systems (CAPA, internal audit, complaint management, documentation management, among others), Six Sigma, Lean, or Practical Process Improvement
Must have understanding of validation, calibration, preventive maintenance, electronic records, among others
Skilled at root cause analysis and problem solving with a results orientation
Strong customer focused and collaboration skills
Experienced in dealing with customers, suppliers, and senior management
Experienced internal and external auditor
Ability to travel 25-40% of the time
MBA / Masters Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics
Lead auditor experience
Skilled in WMS, Access and/or SQL database experience

Senior Manager, Clinical Quality Assurance Resume Examples & Samples

Lead various quality improvement initiatives in order to comply with Good Clinical Practice (GCP), Good Documentation Practices (GDP), ICH, requirements, SOPs, and applicable regulations
Initiate and/or maintain the development of GCP and GVP quality systems and SOPs in compliance with applicable regulatory requirements, and supports department infrastructure development
Develop GCP, GVP audit plans and implementation of the audits necessary to ensure clinical trials and nonclinical studies are conducted in compliance with applicable study protocols, and regulatory requirements
Conduct audits of US and international GCP or GVP vendors
Conduct audits of clinical study and regulatory submission documents, including Clinical Study Reports, Trial Master Files, and Safety Reports
Conduct internal system/process audits to ensure compliance with company policies/procedures and GCP and GVP regulations
Ensure all audit-related corrective and preventive actions are followed up through completion
Provide GCP, GVP QA advice to Clinical Operations and Development, Nonclinical Safety, Drug Safety and Pharmacovigilance based on interpretation of current regulations to assure best practices
Conduct GCP, and GVP training to internal departments as applicable
Supports regulatory authority inspection readiness activities, inspection support (e.g., front-room, or back-room), and coordination of responses
Performs investigations of GCP and GVP-related matters
Reports significant quality deficiencies to CQA management
Prepares metric reports to relevant management

Quality Assurance Senior Manager Resume Examples & Samples

Manages the development, implementation and administration of QA procedures, policies, programs and systems for all consumable private label programs
Acts as recall coordinator for consumable private brands and communicates across all necessary areas (legal, merchandising, store operations). Works with suppliers to approve corrective action plans. Monitors for completion and audits facilities when necessary to ensure compliance
Drives private label growth through by managing and maintaining a private label quality assurance testing and product quality monitoring program for new and on-going items and ensures issues are corrected in a timely manner. Acts as a vendor liaison to ensure compliance with all QA policies
Partners with the call center to monitor and analyze customer complaints and safety concerns for all private label items. Responds to written customer complaints accordingly. Follows up with suppliers to ensure customer concerns are addressed and to determine if there are manufacturing problems requiring corrective action. Approves corrective action plans and monitors for completion. Use customer feedback to drive continuous improvement of products
Gathers and maintains necessary documentation and information from suppliers to determine if company requirements are met. Identifies manufacturers who are not able to meet established quality standards. Qualifies domestic and international suppliers. Reviews third-party GMP audits and corrective action documents for all manufacturing facilities
Audits supplier facilities as necessary. Follows up on correction actions and performs re-audits as necessary
Manages QA department annual budget
Technical and working knowledge of quality assurance principles, processes and techniques
In-depth knowledge of third-party GMP auditing schemes and GFSI standards
A collaborative style that can demonstrate the ability to interact and influence many teams to reach their goals
Good analytical skills to gather and interpret technical information, and to develop, recommend and implement solutions
Knowledge of basic lab equipment, such as pH meter, viscometer, and microscope
Knowledge of manufacturing plants and sanitation practices across multiple CPG industries

Senior Manager, HR Quality Assurance Resume Examples & Samples

Developing of the Leave & Disability & Accommodations Quality & Self Inspection program
Coordinating with Leave of absence vendors to measure and inspect vendor programs
Developing and monitoring of key leave of absence business metrics
Developing test strategies
Writing test plans and communicating results cross functionally
Working with Develop & Delivery teams to understand product vision and requirements
Defining measurable metrics to gauge progress against objective quality goals
Hiring and developing quality and escalations staff
Bachelor’s degree in Finance, HR or a related field
At least twelve years of audit and/or quality program experience
At least five years of development and/or test management experience with a proven track record in building effective teams and experience hiring and retaining staff
Hands-on experience with test planning, test execution and designing, implementing and maintaining high quality programs
Strong project management skills, preferably with experience in an agile development environment
Solid track record for delivery of high quality products
Advanced degree in Finance, HR or a related field
Experience with leave of absence or disability quality assurance

Senior Manager, Training & Quality Assurance Resume Examples & Samples

Hire, build, and maintain the team of instructional designers, training instructors, QA analysts, and supervisors to meet the growing demands of McKesson Specialty Health
Pragmatic approach in working with people for win-win results
Develop effective assessment tools to identify and determine operational and employee needs
Identify the need for changes in management practices, improvements in hiring practices, enhancements to technologies and tools for both departments
Develop processes and tools for managing resources (training facilities, personnel) and delivery schedules
Provide efficient learning experiences that are effectively targeted at operational needs
Maintain a focus on continuous improvement by using a systemic process to improve quality
Responsible for developing, implementing, and maintaining quality assurance systems, including Quality Assurance monitoring systems, and activities
Hire and build the team of instructional designers with expertise in front end analysis, performance diagnostics, design of learning systems, assessment and evaluation
Establish designer, trainer, and analyst qualifications. Provide training and developmental opportunities, as well as feedback and coaching
Oversee the development and deployment of role-based curriculum for all each program
Develop and mentor direct reports in required skills training, instructional design, job aid design, performance auditing, information mapping, performance evaluation and others as determined by performance results
Partner with and support external vendors to meet their program requirements
Manage all department responsibilities including administration, human resources, budgeting and logistics
Develop and maintain Standard Operating Procedures (SOPs) and departmental Guidance Documents. Oversee stakeholder training on SOPs
Manage content including the selection or building of tools to allow for easy collaboration with internal clients
Provide internal customer tools for easy access to training materials and knowledge assets
Oversee selection, development, testing, and deployment of software learning solutions
Oversee selection, development, testing, deployment and maintenance of software to manage training documents (e.g., Facilitator Guides, slides). Establish version control processes and standards
Oversee selection, development, testing, deployment and maintenance of software to manage training records (completions, assessment scores)
Previous experience in applying best practices and tools for adult learning programs; including program analysis, design, development, implementation, and evaluation
Experience and expertise in Instructional Design methodologies
Contact center Training and Quality Assurance monitoring program experience
Leadership, coaching, team building, and employee development experience for multiple teams with (15 – 35 reports) is essential
Previous project management experience within a cross-functional collaborative environment
Data analysis and root cause analysis experience
Facilitation and presentation experience
Excel, Word, PowerPoint, and WebEx experience
Healthcare industry knowledge, highly preferred

Senior Manager Systems Quality Assurance Resume Examples & Samples

Have led multiple, simultaneous projects
Worked on large, embedded systems
Specialized expertise in establishing testing guidelines and providing technical advice to product development teams regarding the design and delivery of test strategies to accelerate products to market
Familiarity with COTS (common off the shelf) tools
Solid understanding of the art and science of testing
Gaming industry experience preferred
2 years of relevant Hardware/Software testing work experience
2 – 3 year experience in coding and/or Selenium Proficient
Object oriented programing experience ex: JAVA, C++, Ruby
Knowledge or experience with C, C++ and C#
Ability to provide clear direction and leadership to direct reports as well as other groups within Scientific Games Corp
Ability to review requirements for testability
Develop Test Strategies, Test Automation Frameworks, Test Methods, Test Tool Selection
Mentor and Train test engineers on test methods and new technologies
Results oriented, Risk Taking and extensive multi-tasking ability

Quality Assurance Senior Manager Resume Examples & Samples

Manage and coach a growing team of about 10 people (Bachelor/Master level, Quality Assurance)
Ensure released products are at the right quality levels and comply with relevant regulations and Philips policies
Be an ‘ambassador’ for quality assurance and drive improvement
Compliance, effectiveness and efficiency of the QMS
Collaborate with other senior managers to establish strategic plans and objectives
Establish and track quality objectives
Work on issues that require in-depth knowledge of business processes and –objectives
Attract, develop and engage your team members

Quality Assurance Senior Manager Resume Examples & Samples

Knowledge of continuous improvement methodology including Lean and Six Sigma
Audit and/or implementation of ISO 9001 standards
Clear understanding of corrective action/preventative action (CAPA) processes
Capable of concurrently managing multiple projects and delivering quality and timely results
MS Office application proficient
Strong supervisory and interpersonal skills
Working knowledge of SharePoint is preferred
Additional knowledge/skills may be required by assignment or contract and will be listed separately
Bachelor’s degree in associated discipline is required. Two (2) years of experience may be substituted for each year of required education
Ten (10) years of quality assurance experience with three (3) years in a quality management role required
Lean and Six Sigma implementation project completion and Black Belt Certification preferred; Green Belt Certification required as a minimum
Experience establishing, maintaining, and improving a Quality Management System
Additional experience/education may be required by assignment or contract and will be listed separately

Senior Manager Pharmacovigilance Quality Assurance Resume Examples & Samples

Together with the Regional Lead of Pharmacovigilance Quality Assurance in the respective region in the implementation and refinement of processes to ensure that Takeda maintains oversight of the quality of its pharmacovigilance activities in compliance with applicable regulatory requirements
Implement of the strategy for regional Pharmacovigilance quality oversight to ensure that Takeda meets its sponsor and marketing authorization holder obligations to protect the safety of study subjects and patients
Plan and conduct Pharmacovigilance system audits in support of global PV activity for post marketed and clinical development products, including TDC, TPNA and marketing licensees to assure compliance with the Code of Federal Regulations, EU Directive, local regulations, ICH and Takeda policies and procedures
Obtain audit responses from Pharmacovigilance and external partners/vendors and evaluate proposed corrections, corrective actions, and/or preventative actions for compliance with applicable regulations, guidelines, and Takeda policies. Facilitate risk mitigation and escalate inadequate audit responses to management
Provide support, guidance and training to external contract auditors, review plans and audit reports
Contribute to the development of process improvement initiatives that enhance regulatory compliance and PV QA efficiencies

Senior Manager Pharmacovigilance Quality Assurance Resume Examples & Samples

Collaborate with GxP colleagues in QA groups and with colleagues at TDC to deliver joint audits (i.e. at the GMP-PV interface and validation, computer system audits)
Provide input into SOP updates and review all TDC, TPC Global SOPs for PV
Collaborate with PV Departments within all assigned Takeda LOCs, Regions, for the development and delivery of PV training programs
Maintain up-to-date knowledge of PV legislation requirements and communicate and actively liaise with PV Departments within Takeda Europe Region locations to exchange information on emerging Regulatory requirements, industry trends
Maintain an active interest in industry trends through networks, training opportunities and professional conferences and forum

Senior Manager, Global Quality Assurance Resume Examples & Samples

Develop, review and signoff on strategic deliverables, metrics, and SLAs that advance GQE goals and objectives
Lead a dedicated team of software development engineers in test (SDETs), test architects, consultants and manager
Provide analysis and review of automation frameworks and processes to be employed across online, mobile and/or key platforms
Experience in managing embedded studio testing methods

Senior Manager of Quality Assurance Resume Examples & Samples

The Senior Quality Assurance Manager will lead Quality responsibilities to fulfill customer quality expectations, product specifications, and requirements
Drive a QA cultural shift from a reactive approach of firefighting to a Proactive approach of well-conceived factory controls
Coordinate root cause analysis of field issues, generate 8D report, and drive issue resolution
Head continuous improvement through good communication with all departments involved
Lead customer audits at both factories located in Baoying (GTY/UEY) and provide closure of corrective actions
Provide monthly metrics to VP of Global Quality Assurance and Senior Management in Asia
Drive key quality metrics improvements and initiatives to increase Open-Box -audit (OBA) and First-Pass-Yield (FPY) performance while reducing customer complaints and scrap rate
Training/certify inspectors at on cosmetic inspection
Guide QMS Data Collection Analysis and Improvements

Senior Manager, Agency Quality Assurance Resume Examples & Samples

Monitor and evaluate all training implementation & activities for trainers to meet all required training standards
Provide suggestions/ideas to improve quality of all training activities and programs, and work with CPD team members for implementing continuous improvement
Any other tasks/ projects of CPD when the need arises
Minimum 10 years relevant work experience in life insurance company, preferably in Alternate Distributions
Knowledge of Telemarketing operations, prefered
Preferably obtain some basic life insurance qualifications

Senior Manager Manufacturing Quality Assurance Resume Examples & Samples

Strong leadership skills, verbal and written communications skills
Knowledge of Manufacturing practices and processes
Knowledge of food plant sanitation and laboratory techniques (physical, microbiological and chemical testing)
Knowledge of GFSI/SQF standards and certification process
Working knowledge of computer applications, accounting and budgeting as they affect plant operations
Food manufacturing experience strongly preferred

Quality Assurance Senior Manager Resume Examples & Samples

Demonstrated ability to manage both onshore and offshore resources
Strong process adherence experience
Demonstrated ability to work collaboratively with other teams
ISO9001 Experience

Quality Assurance Senior Audit Manager Resume Examples & Samples

Develop and drive enhancements to selected training materials
Seek ways to increase efficiency and effectiveness of work performed
12+ years experience within internal audit, with five years of management experience preferred

Senior Manager Systems Quality Assurance Resume Examples & Samples

To manage System Test projects
Drive Continuous Process Improvement in order to reduce test cycle times and escaped defects to the field
To establish key contacts with upstream organizations and external customers that have a direct impact on deliverables
Consult with project teams, review their requirements, designs and planned functionality from a quality and test perspective
Define and assess test (verification and validation) practices, standards, processes, and skills at the Department and Project level
Understand business drivers, quality risks, and tradeoffs with the ability to propose risk mitigation approaches to meet the business need
To attend meetings in-person when needed to gain insight into customer requirements
Develop and gain approval on high level test strategies
Provide review input on test plans and test cases
Drive results / define strategies for automation solutions as a critical part of testing
4 - 6 years of relevant Hardware/Software testing work experience
High level of managerial skills

Senior Manager of Quality Assurance Resume Examples & Samples

Develop, implement, manage, audit, and maintain Quality Systems (GXP compliant) for development and commercial activities at a specialty pharmaceutical firm
Plan and execute internal and external audits
Review, approve, and release non-conformances
Review and approve development documentation
Assure all operations – manufacturing, packaging and testing – are compliant with internal SOPs and industry regulations
Assign disposition to all products (bulk, intermediate, finished and components) manufactured and packaged through: reviewing and evaluating batch records, evaluating product trends, interpreting and implementing product control requirements, and evaluating notice-of-event reports (i.e. deviation reports) and cross-functional investigations
Troubleshoot issues in the manufacturing and packaging process and perform CAPAs as necessary
Manage compendia changes
Manage and evaluate change controls
Be visible in the plant and monitor all manufacturing activities, including product labeling

Senior Manager Global Quality Assurance Resume Examples & Samples

Master degree : Microbiology, Biochemistry, Bio-engineering, Pharmacy, Food aseptic production
Minimum 5 years’ experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment
Recognized as expert within GSK (GMS and Vaccines) in the different domains of sterility assurance
Personal credibility, confidence and robustness to drive and influence a network of experts
Ability to make persuasive recommendations based on rationale analysis
Able to network internally (GMS included) and externally and to communicate to a wide base of partners
Strong verbal and written English language skills
In depth knowledge of regulations, guidance, and industry standards related to sterility assurance (for example: GSK, GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc.)
Strong technical and quality skills in sterility assurance issue
Resilience, capacity for adapting in different environment and resistance to pressure
Support – Provide/coordinate network technical expertise for continuous improvement and troubleshooting. Consolidate and pull technical expertise and support manufacturing improvement programs to ensure harmonization and quality across products, processes and sites with the aim to guarantee quality and timely delivery to our customers. Influence the organization to drive transversal improvement programs
Knowledge – Develop/coordinate and ensure proper training and certifications, skill assessments, coordination of a network of experts. Lead benchmarking (internal and external) to ensure GSK is state-of-art as required. Develop the group as a reference center within the GIO/Q network for all matters related to SA domain. Is the reference for interactions with regulatory bodies (Type-C meeting, regulatory inspections, etc.)
Recognized internally and externally as the quality expert on regulation, guidance and industry standards related to sterility assurance principles. Develop and give presentations at international conferences (PDA, ISPE, etc.)
Direction/Guidance: Top Down

Senior Manager, Portfolio Quality Assurance Resume Examples & Samples

Establish overall governance and Control function; defining processes and structure across TRMIS PMO for management of Cyber Portfolio of Programs/Projects
Responsible to ensure all TRMIS teams are complying with the system development life cycle (SDLC) and project management methodology (PDLC, Agile, Rapid) – by establishing a gating criteria, forecasts for all deliverables, estimates of scope and cost, along with business cases
Develop strategies for adopting the EPMO Accelerated Delivery and Iterative Methodologies in TRMIS
Provide an independent and objective oversight to the Program/Project Management Team with a mechanism to positively influence outcome of Programs/Projects
Enhance the integration of the Business and IT Teams ensuring consistency & best practices
Improve delivery of key initiatives through the implementation of a hybrid model of Quality Assurance & Quality Control
Expert knowledge of Bank and project delivery practices (PDLC/SDLC)
Strong Program/Project governance and delivery background
Advanced and thorough understanding of businesses and/or organizational practices/ disciplines
Ability to influence and impact without authority
Ability to deal with complex analysis with conflicting priorities
Identify obstacles to success of initiatives and adjust/escalate appropriately
Comfortable working in an extremely dynamic environment
A change leader who is highly flexible and able to quickly adapt to changing priorities
Strong interpersonal skills with excellent oral and written communication skills
A strong team-player with a passion to improve the business
Highly organized, self-motivated, and ability to work independently
Excellent facilitator and negotiator with a proven track record as an excellent leader
Strong listening and influencing skills to foster an open, innovative and responsive environment and to drive change
Ability to operate at senior levels to develop effective responses to objectives
Promote and support an environment that encourages productivity, innovation, teamwork, and a high level of professionalism