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QA Manager (Suppliers and Material Release)

Company: FDBT - FUJIFILM Diosynth
Location: Morrisville
Posted on: May 5, 2021

Job Description:

Overview 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. External US The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.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 OrganizationMinimum Education Requirements
      • BS/BADesired Experience
        • 10+ years of applicable experienceFDBU 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.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: FDBT - FUJIFILM Diosynth, Cary , QA Manager (Suppliers and Material Release), Executive , Morrisville, North Carolina

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