JOB DESCRIPTION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 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 efficiency in their laboratories, we are here to support them. Our team of more than 100,000 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, Patheon and PPD. For more information, please visit www.thermofisher.com.

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.

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.

QUALIFICATIONS:

• Bachelor’s degree in a scientific or technical subject area required; advanced degree preferred

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

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