Director, Quality

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Viral Vector Services (VVS), part of Thermo Fisher Scientific is a dynamic gene therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Reporting to the Sr. Director Quality, this position is based in our Lexington, Massachusetts site.

Discover Impactful Work

As a member of the site leadership team, you lead the quality strategy for the facility and ensuring alignment with Manufacturing and other support functions. The successful candidate will have extensive experience in a GMP quality function and a strong understanding of Quality procedures, processes, and guidelines.

A day in the Life

Implement quality strategies at the plant floor levelOversee lot disposition of Drug Substance and Drug ProductAct as the lead expert for significant quality or compliance issuesManage the budget and resources to ensure high-quality levels and efficiencyDevelop and maintain quality systems consistent with global requirements, corporate standards, and current regulatory requirementsOversee all aspects of QA operations, including executed batch record review, material release, deviation investigations, change controls, and customer quality supportEnsure QA support for internal and external project and team meetingsProvide leadership and manage the quality function at the plant level, and Collaborate across VVS sites to support and drive Quality initiatives and projects where necessary.Communicate customer, regulatory, and organizational requirements to assure product quality and customer satisfactionCoordinate necessary personnel for internal, customer, and third party quality system audits

Education

BS in Biological Science or a related technical field

Experience

Qualifications

Minimum of 10-15 years of related experience in the Quality UnitExcellent organizational and time management skillsStrong interpersonal and communication skillsExperience leading conversations with customers (internal and external)Understanding of applicable regulatory requirementsExtensive exposure to cGMP environment

Physical Requirements: This job has physical demands that will be discussed during the application process.

Benefits

We offer competitive remuneration, annual incentive plan bonus, 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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