FUJIFILM

  • QA Manager, Product Release/Operations

    Job Locations US-NC-Morrisville
    Posted Date 1 week ago(10/15/2019 1:47 PM)
    Requisition ID
    2019-4156
    Category
    Quality Assurance
    Company (Portal Searching)
    FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
  • Overview

    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.

     

    The QA Manager is responsible for specific quality and compliance areas within Quality Assurance for a site. They will manage Quality Assurance systems and staff to meet site quality and compliance expectations. Other responsibilities include being a customer liaison, acting as the project compliance lead for manufacturing readiness (including process validation programs), being the Quality SME during customer audits and health authority inspections, and quality oversight for batch record review, deviation review and closure, managing customer requirements, and final product quality decisions.  

    External US

     

    MAJOR ACTIVITIES AND RESPONSIBILITIES:

    • Responsible for product disposition, to include batch record review, data review, deviation / event review and closure, change management review / closure, facility assessments and manage external customer expectations for these document reviews for product release.  
    • Host external customer audits representing FDBU Quality Systems
    • Lead Quality compliance efforts for manufacturing readiness
    • Manage the work and continuous improvements necessary to meet requirements for assigned compliance areas on time and right-first-time
    • Compliance SME and may lead compliance projects
    • Manage and develop assigned employees / compliance programs by setting clear expectations, monitoring of performance, regular feedback, and continuous improvements
    • Keep current with required site training and external compliance requirements for assigned compliance areas.
    • Set, monitor, and report progress on goals and development activities

    Background Requirements

     

    Education + Years of Experience

    • BS/BA +10 years of experience or;
    • MS/PhD +4 years of experience
    • Management experience
    • SAP 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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