Senior Manager/Associate Director, QA Batch Release

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.

We are seeking a highly motivated individual to join us as a Senior QA Manager/Associate Director of Batch Disposition in our Contract Manufacturing site located in Research Triangle Park, NC.  Primary responsibilities will be to lead the Quality Assurance team responsible for manufacturing support and batch disposition.

Essential Functions and Duties:

  • Ensure shop floor QA presence during critical operations
  • Ensure efficient and compliant systems and processes are in place to disposition each manufactured batch
  • Collaborate with manufacturing to ensure that batch records, deviations, and change controls are compliantly and efficiently executed and approved
  • Support campaign start up activities
  • Ensure review/approval of process validation documentation
  • Responsible for Quality Agreement negotiation, Scope of Work review
  • Coordinate PQR activities, review PQR for accuracy and write executive summary
  • Review relevant portions of client BLA/submission documents to ensure accuracy to process
  • 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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