Quality Assurance Senior Manager Resume Samples

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MK
M Kulas
Michale
Kulas
24791 Tyree Neck
Detroit
MI
+1 (555) 910 6276
24791 Tyree Neck
Detroit
MI
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
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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15 Quality Assurance Senior Manager resume templates

1

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
2

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
3

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
4

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
5

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
6

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
7

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
8

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
9

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
10

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
11

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
12

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
13

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
14

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
15

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
16

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
17

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
18

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
19

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
20

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
21

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
22

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
23

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
24

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
25

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