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Senior Manager/Associate Director of QA

Company: FDBT - FUJIFILM Diosynth
Location: Morrisville
Posted on: November 19, 2021

Job Description:

Overview FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and Manufacturing organization. The development of biopharmaceuticals and advanced therapy products is at the forefront of innovation in science today, and it provides a world of exciting opportunity. At FUJIFILM Diosynth we work in partnership with our customers, helping them to bring their biologics and advanced therapy products from preclinical stage to the patients whose life will be impacted by these therapies. --As part of our team, you will be helping to deliver tomorrow---s medicines, enriching the community and the environment, delivering a healthier world. So if you are looking for an inspiring career at the cutting edge of science then there are opportunities for you at FUJIFILM Diosynth.The Sr. Manager/Associate Director of Quality Assurance is responsible for multiple or complex compliance areas within QA for the site including, managing QA programs, systems, and staff to meet site quality and compliance expectations. The incumbent is responsible for day to day management of the Quality Assurance aspects of client projects. The individual is recognized as a subject matter expert with regard to Quality Assurance practices and procedures and serves as the point-of-contact for--activities for the QA group. In this capacity, the incumbent is a primary point of contact for QA and is responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply and strategy objectives of the company and the department. The individual initiates and oversees projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality or safety enhancement.----In this role, the individual must be able to identify and communicate improvement opportunities and results. The incumbent identifies operational needs for projects, ensuring site/divisional linkage is achieved. The incumbent must be able to identify and address short term, intermediate, and long term issues, and be able to appropriately resolve conflict and prioritize work as necessary. External US The Sr. Manager/Associate Director of Quality Assurance is responsible for multiple or complex compliance areas within QA for the site including, managing QA programs, systems, and staff to meet site quality and compliance expectations. The incumbent is responsible for day to day management of the Quality Assurance aspects of client projects. The individual is recognized as a subject matter expert with regard to Quality Assurance practices and procedures and serves as the point-of-contact for--activities for the QA group. In this capacity, the incumbent is a primary point of contact for QA and is responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply and strategy objectives of the company and the department. The individual initiates and oversees projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality or safety enhancement.----In this role, the individual must be able to identify and communicate improvement opportunities and results. The incumbent identifies operational needs for projects, ensuring site/divisional linkage is achieved. The incumbent must be able to identify and address short term, intermediate, and long term issues, and be able to appropriately resolve conflict and prioritize work as necessary.MAJOR ACTIVITIES AND RESPONSIBILITIES:--

  • Drives regulatory strategy with clients to ensure successful program submissions and approvals.
  • Coordinates, authors and reviews client regulatory submissions, as requested and provides documentation for inclusion in client submissions.
  • Maintains site regulatory master files and implements electronic DMF for the site.
  • Performs regulatory surveillance, interpreting agency documents into site actions.
  • 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. SME for internal and external customers for a broad compliance area
  • Manage and develop assigned employees I 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
  • Employee demonstrates leader behaviors, consistently promotes positive inclusive behaviors, consistently promotes positive team attitude, and supports business objectives
  • Other duties as assigned.BACKGROUND REQUIREMENTS:--
    • BS/BA with 10 years of management experience or MS/PhD with 6 years of management experience
    • Expert problem solving skills to identify and solve problems within the SOP, Std Practice, and regulatory framework. Able to manage cross-functional teams to investigate, recommend improvements to management, and monitor effectiveness of improvements
    • Able to manage cross-functional teams to investigate, recommend improvements to management, and monitor effectiveness of improvements
    • Excellent verbal and written communication skills. Must be comfortable with public speaking and presenting.Physical Requirements
      • Sitting 50- 90%; Standing and walking; 10- 50%; Lifting up to 25 lbs. (Document Boxes) or 50 lbs. (QA Materials group); Ability to use PPE for Manufacturing, warehouse, and Lab AreasFDBU 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 FDBUHR@fujifilm.com--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 , Senior Manager/Associate Director of QA, Executive , Morrisville, North Carolina

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