Manager, Quality Assurance Lot Disposition

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

This position will be site based in Cambridge, MA and will support our Viral Vector Services (VVS Cambridge) business unit of Thermo Fisher Scientific. At VVS Cambridge, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Discover Impactful Work:
The QA Manager of Lot Disposition is responsible for lot disposition for selected contract manufacturing organizations (CMOs) by performing review and approval of QA certificate of release of product and engaging a team of dedicated staff to identify and drive continuous improvement. This role is instrumental in ensuring supply to patients by releasing material produced at Thermo Fisher across both Clinical and Commercial Drug Substance and Drug Product. This position drives functional projects that implement all elements of a mature and robust lot disposition program. These responsibilities involve working closely with GMP QA Oversight functions, QC, QS, and Operations.

A Day in the Life:

• Support the interpretation and implementation of existing and new regulatory requirements and industry best practices.
• Serves as the primary contact for site disposition activities and oversight of the disposition of multiple drug substance and drug product cell and gene therapies.
• Independently perform and manage batch release activities.
• Resolve quality issues and ensure CAPAs are effectively implemented.
• Directs the site disposition management process and approves all site disposition documents in accordance with Standard Operation Procedures (SOPs).
• Partner with cross-functional teams to ensure products are delivered on time and within specification.
• Assist with product recall / stock recovery investigations and reports, as necessary,
• Build and implement foundational programs and systems to ensure all GxP requirements associated with the disposition of product batches are complied with.
• Provide status reports and quality metrics to support management review process.
• Travel may be required, domestic and international.
• Advances a team-based environment, promoting accountability, collaboration, clarity of purpose and goals, and high commitment to achieve business goals.
• Establish collaborative relationships with internal and external stakeholders to ensure timely documentation and resolution of quality issues.
• Serve as the QA Disposition SME including the disposition process for regulatory inspections.
• Identify, author and implement departmental procedures (SOPs) to ensure compliance with applicable GxPs, industry guidance and best practices.
• Facilitates team to perform manufacturing batch record review, master batch record approval and other activities in support of the quality assurance operations.
• Review change controls to determine the need for market controls and make recommendations for implementation of market controls when applicable.
• Leads team of quality professionals that executes operating procedures for the site quality assurance program, which supports disposition of manufactured products.

• 1-2 years of experience leading teams required.
• Demonstrated management skills and business acumen required.
• B.S. in Chemical Engineering, Biochemistry, Biology, or related field with 8 years of industry experience, or a Masters with 3 years of industry experience.

Knowledge, Skills, Abilities

• Knowledge in Operational Excellence and Continuous Improvement is desirable.
• Proficient in biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition, deviation investigations and batch record review.
• Exhibits excellent written and oral communication, leadership and planning skills.
• Strong knowledge of US and EU cGMP regulations and guidance.
• Provides direction and guidance to staff or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Ability to function in a dynamic fast paced environment, balance multiple priorities simultaneously with a high degree of detail and exercise sound judgement.
• Knowledge of electronic systems including any of the following: SAP, LIMS, and TrackWise, is desirable
• Demonstrated ability to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

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