Manager, Product Quality and Lot Disposition @ Thermo Fisher Scientific
Your Application Journey
Email Hiring Manager
Job Details
Overview
Thermo Fisher Scientific, the world leader in serving science, is seeking a Manager, Product Quality and Lot Disposition to ensure uninterrupted supply to patients by maintaining meticulous quality oversight across Clinical and Commercial Drug Substance and Drug Product operations.
Key Responsibilities
- Lead a team of quality professionals for client quality system oversight.
- Act as the primary Quality contact for client engagements and investigations.
- Manage and approve all site disposition documentation per SOPs.
- Deliver quality metrics and status reports for management reviews.
- Develop strong internal and external working relationships to address quality challenges.
- Support product recall and stock recovery investigations.
Qualifications and Experience
Applicants must have a Bachelor’s degree in a scientific or technical field (advanced degree preferred) and minimum 10 years of Quality Assurance experience in biologics, pharmaceuticals, or cell and gene therapy sectors. A proven track record in regulatory inspections (FDA, EMA, Health Canada) and hands-on experience with product disposition and deviation investigations is essential.
Technical Skills and Digital Proficiency
Extensive knowledge of GMP regulations, biotech manufacturing processes, and digital tools such as SAP, LIMS, and TrackWise are required to drive data trending, reporting, and decision-making.
Work Environment and Physical Requirements
This role is based onsite in Plainville, MA. The candidate must comply with strict GMP and cleanroom protocols including wearing appropriate PPE and maintaining professionalism in appearance.
What We Offer
Competitive pay with an annual performance-based bonus, merit increases, comprehensive benefits, career advancement opportunities, and a meaningful connection to a mission that makes the world healthier, cleaner and safer.
Key skills/competency
- Quality Assurance
- GMP
- Lot Disposition
- Regulatory Compliance
- Team Leadership
- Digital Proficiency
- Deviation Investigation
- Client Interaction
- Biotech Manufacturing
- Process Improvement
How to Get Hired at Thermo Fisher Scientific
🎯 Tips for Getting Hired
- Customize Your Resume: Highlight GMP and quality leadership experience.
- Research Thermo Fisher Scientific: Understand their mission and brands.
- Showcase Regulatory Experience: Emphasize FDA, EMA, and Health Canada work.
- Prepare for Technical Questions: Study SAP, LIMS, and TrackWise usage.
- Demonstrate Leadership: Provide examples of team management success.