Manager, Product Quality and Lot Disposition

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Group/Division Summary:
Thermo Fisher Scientific - Viral Vector Services (VVS) is a dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization for our client partners and the patients we serve.

Pharma Services | Viral Vectors | 5 Commerce Drive, Plainville, MA | 100% Onsite

Position Summary:
The Manager, Product Quality and Lot Disposition serves as the Quality representative on client core teams and is responsible for lot disposition activities for the site. This role ensures uninterrupted supply to patients by maintaining meticulous quality oversight across Clinical and Commercial Drug Substance and Drug Product operations. The manager collaborates closely with GMP and Operations to uphold compliance and product integrity.

Key Responsibilities:
Lead a team of quality professionals responsible for oversight and approval of client quality system results, supporting tech transfer and manufacturing execution through final product disposition.

• Act as the primary Quality contact for clients, providing technical expertise and representing the Quality Unit in investigations, studies, trending evaluations, and improvement initiatives.
• Oversee disposition activities for multiple drug substance and drug product programs
• Manage and approve all site disposition documentation in accordance with SOPs.
• Deliver quality metrics and status reports to support management reviews.
• Develop working relationships with internal and external team members to efficiently address quality challenges.
• Support product recall and stock recovery investigations and reporting

Qualifications:
Experience:

• Minimum 10 years in Quality Assurance roles within biologics, pharmaceuticals, or cell and gene therapy sectors
• Consistent record handling regulatory inspections (FDA, EMA, Health Canada)
• Proven success in building and leading impactful teams
• Hands-on experience with product disposition, deviation investigations, and batch record review in GMP environments

Knowledge, Skills & Abilities:

• Extensive knowledge of GMP regulations and global standards (FDA, EMA, Health Canada), with the ability to interpret and implement evolving regulatory requirements and industry standard methodologies.
• Skill in biotech manufacturing processes for both bulk and finished products, including cell and gene therapies. Skilled in product disposition, deviation investigations, and batch record review.
• Digital Proficiency: Knowledge of electronic quality systems like SAP, LIMS, and TrackWise, with the ability to bring data for trending, reporting, and decision-making.
• Leadership & Teamwork: Established ability to lead successful teams, promote cross-functional relationships, and represent the Quality Unit in client-facing engagements and regulatory inspections.
• Critical Thinking: Able to handle intricate disposition workflows, lead ongoing improvement efforts, and contribute to innovative quality operations.
• Communication & Influence: Exhibits strong written and verbal communication skills, proficient in conveying technical concepts to diverse audiences and influencing outcomes with team members and collaborators.

Physical Requirements:

• Ability to gown aseptically and/or sterile gown
• Capacity to write and review written documentation for extended period

What we offer:

• Competitive Pay and Annual performance-based bonus
• Annual merit performance-based increase
• Medical, Dental, & Vision benefits-effective Day
• Paid Time Off & Designated Paid Holidays
• 401K
• Tuition Reimbursement
• Career Advancement Opportunities

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.