FUJIFILM

QA Manager, Product Release and Operations

Job Locations US-NC-Research Triangle Park
Posted Date 4 weeks ago(4/15/2021 1:59 PM)
Requisition ID
2021-14742
Category
Quality Assurance
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

Overview

The QA Manager for Product Release and Operations 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

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 for Product Release and Operations 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. 

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
  • 1+ years of management experience
  • SAP experience
  • Experience working in the biotech or pharmaceutical industry with GMP procedures
  • Experience managing and resolving deviations

Preferred

  • Prior product release experience
  • Experience interacting with clients
  • ASQC certifications

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.

 

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.

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