QA Manager (Suppliers and Material 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 QA Manager in our Contract Manufacturing site located in Research Triangle Park, NC. Primary responsibilities will be to lead the team responsible for supplier qualification and materials release.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Manage the work and continuous improvements necessary to meet requirements for assigned compliance areas on time and right-first-time – 50-80%
  • Compliance SME and may lead compliance projects – 0-20%
  • Manage and develop assigned employees / compliance programs by setting clear expectations, monitoring of performance, regular feedback, and continuous improvements – 10-20%
  • Keep current with required site training and external compliance requirements for assigned compliance areas. Set, monitor, and report progress on goals and development activities – 10 %

Primary responsibilities will be to lead the team responsible for supplier qualification and materials release.

Essential Functions and Duties:

  • Ensure efficient and compliant Quality processes, systems, and procedures regarding audit management
  • Ensure efficient and compliant processes for approving and auditing suppliers of raw materials, consumables, and GMP services
  • Ensure that systems for efficient release of raw materials are defined, compliant, implemented, and executed
  • Represent Supplier Management and Materials Release as the Subject Matter Expert during internal/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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