Sr. Manager Quality Control
Sr. Manager Quality Control
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Salary Not Disclosed
1 Vacancy
Job Description
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 youll 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 worlds 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! Youll 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 sites 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
Bachelors 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.
Required Experience:
Manager
Employment Type
Full-Time
