Quality Assurance Pharmaceutical Quality Systems Lead

Location
Holly Springs, NC
Posted
Sep 30, 2021
Ref
2021-16243
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

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.

External US

We are currently seeking a Quality Assurance Pharmaceutical Quality Systems (PQS) Lead to join us as we build the largest life science and CDMO facility in the US.  

This leadership role will be a key QA partner for the new site to develop and systems, procedures, and staffing to assure quality and cGMP compliance for the PQS and will report to the site Head of Quality and Regulatory.  

The successful candidate will be able to partner prospectively with site management and SMEs to create efficient and cGMP compliant PQS implementation plans, systems, and documents to support plant construction, CQV, and ultimately CDMO operations.  

Job Responsibilities:

Build and lead a team of QA PQS SMEs to provide quality assurance systems and expertise to support all aspects of plant construction, CQV, and ultimately CDMO operations

Provide quality assurance partnership with global quality partners, site management and SMEs to establish an efficient and effective cGMP compliant PQS

Leverage existing PQS systems, processes, procedures, and documents from other Fujifilm facilities, where possible, to provide efficient, effective, agile, and aligned QA PQS including systems for, but not limited to: Change Control; Deviations; CAPAs; Document Management; Supplier Quality Management; Education and Training; Internal, Customer, and Regulatory Audits; Management Quality Review; etc 

Assure suitability and cGMP compliance of all systems and documentation for the PQS through prospective project management and document approvals of the PQS components

Create and maintain reliable concise planning and tracking of assigned responsibilities and functions

Basic Requirements:

Bring contagious positive enthusiasm and an agile proactive mindset to quality and cGMP compliance

Minimum of 12 years PQS Biotech experience on with experience in establishing harmonized PQS systems in a global network some of which includes time in a leadership role prefer additional cross functional experience in other operational areas such as manufacturing, QC, engineering, etc

Have current knowledge of Biotech Drug Substance and Drug Product multinational cGMP requirements for to support the PQS and cGMP operations for the site

Capable of partnering to assure suitability and/or cGMP compliance of the PQS and ability to defend these systems to customer and regulatory partners

Have knowledge of multi product CDMO facilities and the ability to negotiate quality agreements and navigate the intricacies of interfacing with multiple customer PQS

Have excellent communication / presentation skills, and be able to articulate complex information to stakeholders and partners that utilize PQS systems including regulators and customers

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

 

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 email 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.