Senior QA Manager (Systems and Compliance)

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

Position Summary:

We are seeking a highly motivated individual to join us as a Senior QA Manager of Systems and Compliance in our Contract Manufacturing site located in Research Triangle Park, NC.

Primary responsibilities will be to lead the Quality Assurance team responsible for Quality Systems and Compliance. Hands on experience managing site preparation and back room operations during health authority inspections is essential. Successful candidate will have a proven track record of leading teams and collaborating cross functionally. Experience with TrackWise and/or MasterControl preferred.

Essential Functions and Duties:

  • Manage QA programs, systems, and staff to meet site quality and compliance expectations
  • Ensure efficient and compliant quality systems and processes are in place to meet cGMP and FDB requirements
  • Develop, obtain approval, and execute the strategy to prepare for health authority inspections and lead any follow up activities
  • Manage back room operations for health authority inspections
  • Manage all aspects of due diligence and customer audits including leading/hosting
  • Collaborate with regulatory affairs to keep site systems current with changing regulations
  • Site owner of Deviation, CAPA, Change Control, and document control/archival systems
  • Represent Quality Assurance for internal and external audits and regulatory inspections
  • Provide cross-functional support within the QA Organization

Minimum Education Requirements

  • BS/BA Desired Experience
  • 10+ years of applicable experience

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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