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Manager, QA

Company: ThermoFisher
Location: Somerville
Posted on: September 21, 2022

Job Description:

Manager, QA OperationsThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .Location/Division Specific InformationThis position reports into the Cambridge, MA site of Viral Vector Services (VVS) and reports to the Head of QA Operations. How will you make an impact?The Manager, QA Operations will be the primary point of contact for the customer on all matters related to batch record review. This position requires a highly motivated, tenacious leader who can assimilate new information quickly and enjoys working closely with others within a fast-paced environment. The individual will lead and manage the team that perform activities in support of dispositioning product while ensuring compliance with VVS directives and procedures, customer requirements, and regulatory standards.What will you do?Responsible for contributing to and leading initiatives to key functional, tactical, and operational aspects of VVS operations at the Cambridge site. Responsible for actively participating as a member of the Quality Ops Leadership Team and partnering with Operations management. Responsible for supporting manufacturing operations and ensuring unexpected events are handled compliantly and in a timely manner. Responsible for the review and approval of batch records and supporting documentation. Responsible for client interactions in support of batch record approval. Responsible for evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate & approve these quality system elements. Additional responsibilities may include support in deviations, CAPAs, change controls, and documentation issuance. This role will:Manage the team that reviews and approves batch records and supporting manufacturing documentationCoordinate closure of GMP documents to support batch record closure and lot dispositionProvide quality support for manufacturing operationsParticipate in deviation, CAPA, change control, and documentation activities, as neededProvide SME support for regulatory inspectionEnsure all quality related activities are performedResolve Quality related issuesPartner with functional leaders to identify key performance metrics and develop a plan for routine measurement. Management of data review, analysis, identification of trends, and complex problem solvingChampion continuous improvement effortsSupport a state of continued inspection readinessHow will you get here?Bachelor's Degree in Sciences with 6+ years preferred experience in a quality leadership position, or > 10 years progressive management experience with GMP responsibilities within the biological and/or pharmaceutical industrySolid understanding of US, EU and ROW cGMP guidelines and requirements including ability to apply to all aspects of the positionAbility to understand operational documents for GMP compliance, accuracy and completenessStrong client-facing interpersonal skills coupled with a concern for impact.Strong time management and organizational skillsExcellent written and oral communication skills both internal and externalAbility to resolve conflictStrong leadership skills- including ability to lead a team through multiple priorities in a fast paced environmentStrong attention to detailStrong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse communityExperience with manufacturing operations is a plusPHYSICAL DEMANDS/FACTORS:Ability to function in a rapidly changing environment & handle multiple priorities. A flexible work schedule is required.Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Job SummaryJob number: 217549BRDate posted : 2022-09-12Profession: Quality & RegulatoryEmployment type: Full-Time

Keywords: ThermoFisher, Somerville , Manager, QA, Executive , Somerville, Massachusetts

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