We are looking for a Pharmaceutical Quality System (PQS) Manager, who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. As the PQS Manager for the site, you will have direct impact on establishing the PQS of a $2 billion Greenfield CDMO facility.
In the project phase, your main responsibility as the PQS Manager will be to establish PQS in accordance with ICHQ10 and cGMP guidelines. Provide Quality Assurance partnership with global quality partners, site management and SMEs to establish an efficient and effective cGMP compliant PQS. You will partner with other areas within the project, as well as QA departments at other FujiFilm sites to leverage existing PQS systems, processes, procedures, and documents, where possible, to provide efficient, effective, agile, and aligned QA PQS strategies and procedures.
Once in operations, you will lead a team of QA PQS SME's responsible for ensuring that systems and processes are maintained in a compliant state throughout product lifecycle, with a focus on consistent operational monitoring (performance indicators) and continuous improvement. Additionally, you will lead and participate in client audits and regulatory agency inspections.
Deliver effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. The PQS Lead will establish PQS procedures and manage the primary PQS systems including the system elements (such as complaints, deviations, audits and inspections) but are not limited to the following.
- Change Management
- Corrective Action and Preventive Action
- Process Performance and Product Quality Monitoring System
- Management Review
- International and domestic travel required
- You should expect the role and responsibilities to develop and evolve as the project group expands, and subsequently moves into operations.
- Have current knowledge of Biotech Drug Substance and Drug Product multinational cGMP requirements to support the PQS and cGMP operations for the site.
- Bring contagious positive enthusiasm and an agile proactive mindset to quality and cGMP compliance.
- 10+ years' of PQS Biotech experience with 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..
- 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 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.
The Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.
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 .
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.