JOB TITLE: Sr. Manager, Quality Systems

LOCATION: Cambridge, MA

At Global Viral Vector Services (VVS), 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 Sr. Manager will assist in the development and maintenance of Brammer Bio’s Quality Management System. The scope of this roles includes evaluating, developing, implementing, and managing the Global VVS Quality Management System (QMS) and acting as the Quality Systems champion across all operational sites (Cambridge, Lexington, Alachua, Plainville) to ensure alignment/adherence to the QMS directives and applicable regulations.

This Sr. Manager will assist with the implementation of and will maintain a quality process structure across VVS. This process structure or network of communities of practice (CoOP) will facilitate compliant best-practices across the Global VVS Quality System, will provide process metrics and results and facilitate continuous improvement of the QS. This Sr. Manager will support the integration of VVS into the overall PSG Quality System.

WHAT WILL YOU DO?

You will provide support for Global VVS Quality programs and activities and often lead or facilitate efforts related to the development and continuous improvement of the division’s QMS, especially as it relates to the key Quality processes of deviations, CAPA, change control, and risk.

You will facilitate the Global VVS Quality Management Review. You will partner cross-functionally to effectively work across all sites to ensure harmonization with respect to QMS implementation and compliance. The ideal candidate must be a strategic thinker, excellent communicator, collaborative and have experience in the design, implementation, and continuous improvement of quality processes.

• Develop or assist with the development of QMS standards, policies and SOPs

• Provide oversight for implementation of new standards, policies and SOPs

• Works collaboratively to ensure implementation and compliance with the Quality Standards and systems across all sites

• Partner with Global PSG quality system resources to implement a One PSG Quality System and support its continuous improvement

• Organizes and facilitates the periodic Quality Management Review (QMR) and Quality Council Meetings

• Supports a state of continuous inspection readiness as a subject matter expert for the VVS QS during external audits, as necessary

• Assists in establishing and providing reports related to the implementation and performance of the QMS, making recommendations for continuous improvement as applicable

Education

• Bachelor’s Degree in related field or equivalent experience

Experience

• Minimum of 8 years of overall professional work experience, with 5 years in biotech/pharma
• 2 years prior management experience preferred, including oversight of contractors
• At least 5 years of direct GMP experience
• Experience interacting with external auditors as an SME
• Must have advanced experience with TrackWise

KNOWLEDGE, SKILLS, ABILITIES

• Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals
• Experience with Quality Management System implementation
• Excellent organizational skills and analytical and problem-solving abilities, strong verbal and writing skills and good interpersonal and leadership skills
• Possesses exceptional time management and multi-tasking abilities to meet commitments and deadlines

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