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, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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.

Location/Division Specific Information

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

Discover Impactful Work:

We are seeking a dynamic and strategic Sr. Manager, Quality Control, to lead all Quality Control operations at our Plainville site. This is a key leadership role for someone passionate about quality, team development, and innovation in advanced therapies! You’ll ensure the successful execution of in-process and release testing, method validation, and compliance with global regulatory standards — while shaping the future of our QC organization.

A Day in the Life:

Lead with vision: Act as a member of the Site Quality Leadership Team and foster a culture of quality and continuous improvement.

Develop talent: Lead and mentor an impactful QC team, driving engagement, capability, and career growth.

Drive operational excellence: Ensure timely testing, method qualification, and effective execution of QC programs.

Be inspection-ready: Serve as the site’s QC lead for client audits and regulatory inspections (FDA, EMA, Health Canada).

Enable innovation: Support digital transformation initiatives including the implementation of electronic LIMS.

Manage performance: Be responsible for the QC budget, resource planning, and performance metrics.

Advance science: Play a key role in supporting the delivery of innovative gene therapies to patients worldwide.

Keys to Success:

Education

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

Advanced degree (MS or PhD) strongly preferred.

Experience:

At least 10 years in Quality Control or Quality leadership roles within the biologics, pharmaceutical, or cell and gene therapy industry.

Experience handling regulatory inspections, including FDA, EMA, and Health Canada.

Demonstrated success in building, leading, and developing impactful teams.

Background in analytical method validation and technology transfer in a GMP environment.

Experience with Deviations, Lab investigations and OOS required.

Knowledge, Skills, Abilities:

Deep understanding of GMP regulations, ICH guidelines, and global regulatory expectations.

Strong organizational, planning, and prioritization skills.

Clear and confident communicator with excellent presentation and partner engagement skills.

Proficient in analytical problem-solving and technical report writing

Comfortable navigating digital systems and supporting LIMS implementation.

Collaborative leadership style with a continuous improvement approach.

Physical Requirements:

Ability to work in a laboratory or office environment with extended periods of sitting, standing, or walking.

May require occasional gowning for entry into cleanroom or controlled environments.

Ability to lift up to 25 pounds occasionally.

Ability to use a computer and standard office equipment for extended periods.

Visual acuity and manual dexterity to perform analytical or data review tasks.

May occasionally require flexibility to support off-shift or weekend activities during audits or critical operations.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.