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QA Director

Company: FUJIFILM Holdings America Corporation
Location: Morrisville
Posted on: November 26, 2022

Job Description:

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 Are you ready to make a difference in patient's lives? Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a QA Director for its Client Programs team. Join us to help shepherd client programs in all stages of development and commercial production. The successful candidate is responsible for site Quality Assurance functions and cGMP Compliance for client programs. 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 control, analytical development, and process development, to meet site business objectives. Oversee 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.MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Manage development, implementation, and continuous improvement of quality systems
  • 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 activitiesBACKGROUND REQUIREMENTS:
    • Education + Years' Experience + Years Management Experience: BS/BA / 6 or MS/PhD / 6
    • Expert problem-solving skills to identify and solve problems within the Quality Assurance scope of the position. Must be able to sponsor and manage cross-functional teams to investigate, improve, and monitor effectiveness of improvements.
    • Must be adept at leading complex cGMP decision making and resolution of conflict with cross functional internal and external partners. A positive customer focused approach to assuring quality and compliance while meeting business objectives is key.
    • Communicate cross functionally with peers, senior management, external customers and regulators in oral, presentation, and written forms. Must be skilled at handling quality and compliance escalation issues in a collaborative manner that strengthens internal and external partnerships.
    • This position requires results-oriented leadership behaviors that promote positive relationships with internal and external partners. The Quality Director must set a personal example and mentor staff to consistently promote positive inclusive behaviors and team attitude with a focus on achieving quality, compliance, and business objectives.
    • Must be able to appropriately apply phase appropriate quality standards and cGMPs.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. If an accommodation to the application process is needed, please e-mail .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: FUJIFILM Holdings America Corporation, Cary , QA Director, Executive , Morrisville, North Carolina

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