Director, Quality

2 weeks ago

Lexington, United States Thermo Fisher Scientific Full time

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**:
**A day in the Life**:

- Implement quality strategies at the plant floor level
- Oversee lot disposition of Drug Substance and Drug Product
- Act as the lead expert for significant quality or compliance issues
- Manage the budget and resources to ensure high-quality levels and efficiency
- Develop and maintain quality systems consistent with global requirements, corporate standards, and current regulatory requirements
- Oversee all aspects of QA operations, including executed batch record review, material release, deviation investigations, change controls, and customer quality support
- Ensure QA support for internal and external project and team meetings
- Provide 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 satisfaction
- Coordinate 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 Unit
- Excellent organizational and time management skills
- Strong interpersonal and communication skills
- Experience leading conversations with customers (internal and external)
- Understanding of applicable regulatory requirements
- Extensive exposure to cGMP environment

**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.

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.

**Accessibility/Disability Access**:

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