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 Senior Manager will oversee the Materials Quality team for VVS by developing and improving program strategies, quality standards and procedures related to the specification, sampling, testing and release of raw materials and components for the global VVS supply chain. Additionally, this Senior Manager will oversee the selection and performance management 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 Quality standards related to material specification, sampling and testing. This includes keeping standards current with regulation and guidance documents.
• Lead and further build the team responsible for VVS Material Quality.
• Manage the Materials Quality 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.
• Develop and own the VVS material qualification strategy and program, including the risk-based program for developing material testing strategies.
• Participate in the supplier selection and qualification process.
• Champion and 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 Senior Manager will deliver results by leading a high-performance team of professionals, and through making significant individual contributions to the development and evolution of the VVS Material Quality 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.
• 10+ years of related industry experience, preferably in biotechnology or human pharmaceuticals
• 5+ 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 developing 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 lab management and/or 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.