FUJIFILM

  • QA Director

    Job Locations US-NC-Morrisville
    Posted Date 4 months ago(2/9/2018 11:32 AM)
    Requisition ID
    2018-2332
    # of Openings
    1
    Category
    Quality Assurance
  • Overview

    Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a QA Director. The successful candidate is responsible for site Quality Assurance functions and cGMP Compliance. This position manages Quality Assurance staff to develop, implement, administer, and continuously improve quality systems, documentation, and practices. These systems are expected to meet cGMP and corporate quality expectations. The QA Director also manages quality assurance operations support of manufacturing, quality control, analytical development, process development, supply chain, and engineering to meet site business objectives. Quality operations support includes all Quality Assurance functions to facilitate process development, manufacture, and release of APIs throughout the program lifecycle. We are a biotechnology API contract development and manufacturing organization (CDMO) with customer programs from early development through commercial manufacturing. The QA Director must be able to provide quality and compliance leadership utilizing phase appropriate quality standards and cGMPs to meet the dynamic needs of our customer programs

    External US

    Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a QA Director. The successful candidate is responsible for site Quality Assurance functions and cGMP Compliance. This position manages Quality Assurance staff to develop, implement, administer, and continuously improve quality systems, documentation, and practices. These systems are expected to meet cGMP and corporate quality expectations. The QA Director also manages quality assurance operations support of manufacturing, quality control, analytical development, process development, supply chain, and engineering to meet site business objectives. Quality operations support includes all Quality Assurance functions to facilitate process development, manufacture, and release of APIs throughout the program lifecycle. We are a biotechnology API contract development and manufacturing organization (CDMO) with customer programs from early development through commercial manufacturing. The QA Director must be able to provide quality and compliance leadership utilizing phase appropriate quality standards and cGMPs to meet the dynamic needs of our customer programs.

     

    Main areas of responsibility include:

    Manage development, implementation, and continuous improvement of quality systems

    Manage quality operations support of the site

    Direct and mentor staff by setting clear expectations, performance monitoring, regular feedback, and continuous improvement plans

    Keep current with required training and cGMP expectations for the site. Set, monitor, and report progress on goals and development activities

     

    Education + Years’ Experience + Years Management Experience

    BS/BA +10 / 6 or MS/PhD+10 / 6

     

    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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