QA Document Control Supervisor - PQS

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. Responsible for the supervision of the PQS-Quality applications team applicable to Document Management.

Site Business System Owner for EDMS Control. Applies system expertise and business knowledge to act as primary point of contact and maintain deep understanding of the system and process functionality/improvements and how they apply locally and globally to the system.

Gather recommendations for enhancements and gaps related to the system and in collaboration with leadership prioritize and implement solutions accordingly.

Maintain relationships with site-based costumers and global colleagues and provide updates to leadership as requested.

As System administrator, perform advanced system administration including but not limited to user management, user support, problem solving and system training. Be active in all global advisory boards for each system that you are responsible for. 

External US

Job Description:

• Supervision of the PQS-Quality applications team, ensuring allocation of adequate resources for scanning, archiving, issuing tasks and administration tasks of the enterprise quality systems, applicable to Master Control.


• Support organization in relation to use of application, user access, system support. Drive troubleshooting, analysis and recommendations for process and system improvements 


• Maintenance of applications including support of system configuration and system improvements. Create and maintain application documentation.


• Provide guidance and development of team including team training/knowledge for future business needs and rapid growth expansion


• Support Audits and Inspections as Subject Matter Expert. Maintain internal training level and keep up to date on cGMPs and regulatory requirements


• Provide training in Master Control application and processes


• Support the understanding, flow and use of the document management system for GMP documentation. Perform Doc Admin tasks in document management system. Provide training as needed.

Required Skills:

• Bring contagious positive enthusiasm and an agile proactive mindset to Document Management Systems.


• Supervisory experience


• Excellent oral and written communication skills


• Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills.


• Knowledge and application of cGMP compliance and other related regulations


• Experience with EDMS (Electronic Document Management Systems) preferably Master Control platform and systems applicable to the pharmaceutical industry.


• Ability to work in a challenging environment with frequent interruptions, changing priorities and deadlines


• Ability to identify and creatively resolve multi-disciplinary conflicts


• Demonstrated success facilitating and /or leading functional teams to consensus

Preferred Skills:

• Experience with cGMP EDMS required


• Experience working within a GMP environment


• High School Diploma and 5 years experience working in Document Management (start-up experience a plus)

FDBN 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.

FDBN 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 email lena.lee@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.