Senior Manager Quality Operations and Systems

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 multifaceted 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:  

We are in search of a forward-thinking Senior Manager for Quality to lead all aspects of the Quality Operations and Quality Systems at our facility. This is a pivotal leadership role for someone passionate about quality, team development, and innovation in advanced therapies. You’ll provide operational quality oversight and ensure compliance and inspection readiness in-line with global regulatory standards—while shaping the future of our Quality organization. 

Key Responsibilities:  

• Guide and empower a team of professionals specializing in Quality Operations and Systems, assisting with GMP manufacturing and warehouse operations 

• Ensure inspection readiness and regulatory compliance across all site quality systems 

• Lead all aspects of Supply Chain Quality, including supplier management, change notifications, and corrective actions 

• Develop a culture of quality by directing teams through policies, procedures, and guidelines 

• Establish culture of real-time quality oversight for manufacturing floor events and documentation review 

• Track and report key performance indicators to assess quality system effectiveness 

• Represent the site during regulatory inspections, corporate audits, and client visits 

• Drive risk management initiatives, including risk register updates and mitigation strategies 

• Collaborate cross-functionally on continuous improvement projects to elevate site performance and customer satisfaction. 

• Serve as a strategic partner to clients, addressing quality-related inquiries and aligning product control strategies 

Qualifications:  

• Bachelor’s degree in a scientific or technical field required 

Experience:  

• 10+ years in Quality Assurance or leadership roles within biologics, pharmaceuticals, or cell/gene therapy 

• Strong knowledge of 21 CFR, ICH Q9/Q10, ISO-14644, GAMP5, ASTM-E2500, and EU regulations 

• Proven success managing regulatory inspections (FDA, EMA, Health Canada) 

• Hands-on experience with audits, deviation investigations, and GMP batch record review 

• Demonstrated ability to build and lead hard-working teams 

Knowledge, Skills, Abilities  

• Deep understanding of GMP regulations and global quality standards 

• Strategic problem solver with a practical approach to complex quality challenges 

• Excellent communication and presentation skills 

• Strong organizational and prioritization capabilities 

• Skilled in technical writing and analytical problem-solving 

• Collaborative leadership style with a focus on continuous improvement 

• Collaborative leadership style with a continuous improvement mindset  

Physical Requirements:  

• Ability to gown for cleanroom environments 

• Capacity to read and review documentation for extended periods 

• Must be able to talk, hear, sit, and stand for long durations 

• Occasionally required to lift, walk, reach, stoop, kneel, or crouch 

What we offer:  

• Competitive compensation and annual performance bonus 

• Merit-based annual salary increases 

• Medical, dental, and vision benefits starting Day 1 

• Generous paid time off and designated holidays 

• 401(k) with company match 

• Tuition reimbursement 

• Employee referral bonus 

• Career development and advancement opportunities 

OTHER

• Relocation assistance is not provided,
• Must be legally authorized to work in the United States now and in the future, without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening