Supervisor, Quality Control Raw Materials

Job Title: Supervisor, Quality Control Raw Materials VVS

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 productivity in their laboratories, we are here to support them.

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading, and cutting edge, Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

This Supervisor will oversee the process and execution of raw material sampling, testing and release of raw materials and components for the Plainville VVS supply chain. Additionally, this supervisor will oversee the management and performance for contract labs (CTL) used for testing raw materials. This position will be responsible for creating and/or approving Quality records such as deviations, CAPA and change controls related to the team’s area of responsibility.

What will you do?

• Develop and own SOP’s related to sampling and testing of raw materials. This includes keeping standards current with regulation and guidance documents.
• Lead and further build the team responsible for VVS Quality Control, Raw Materials.
• Manage the QC raw materials team to assure on-time sampling, testing and release of materials to meet VVS business needs for clients and internal stakeholders.
• Oversee the CTL network utilized for testing of VVS raw materials, including assessment for selection, resolution of Quality issues, and performance management.
• Participate in the supplier selection and qualification process.
• Drive improvement for Materials Quality processes to assure that they are efficient and effective.
• As required, author, review and approve Quality records including deviations, CAPA, change controls, risk assessment and technical reports.

How will you get here?

This supervisor will deliver results by leading a high-performance team of professionals, and through making significant individual contributions to the development and evolution of the Plainville VVS Quality Control Raw Materials program.This individual will help ensure that materials are specified, evaluated and released with the required Quality attributes in a timely and efficient manner.

• Bachelor’s Degree in Chemistry, Microbiology, Biology or other Life Sciences. Advanced degree is preferred.

• 1 years of leadership experience in management and leadership in Quality Control and/or Quality Assurance

Knowledge, Skills, Abilities

• Working knowledge of current GxP laboratory practices and procedures, preferably related to material quality testing.
• Experience in sampling processes, testing and/or inspection specifications and release procedures for raw materials and components.
• Ability to manage and lead a diverse team responsible for specification development, sampling, testing oversite and release of raw materials and components.
• Experience in oversight of contract testing labs.
• Strong written and verbal communication skills and ability to effectively communicate with internal partners, VVS leaders, clients and external suppliers.
• Ability to define, measure and lead change to improve the effectiveness and efficiency of key business processes.
• Skilled in use of Microsoft Outlook, PowerPoint, Word, Excel and Project programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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.