Manager, QA DSM

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

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.

 

Join us

 

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.

Job Description

About the Role

 

The Manager, QA DSM is responsible for activities during both the project phase and operations. During project phase, the manager's main responsibility is driving quality oversight for the direction of all Drug Substance Manufacturing processes, as well as overseeing validation documentation for these processes. This role works closely with other areas within the project and QA departments at other sites to align strategies and procedures. During operations, the Manager, QA DSM leads the Quality partnership responsible for ensuring that all DSM systems and processes are operated and maintained in a validated state throughout their lifecycle. This role focuses on consistent policy administration and QA oversight of day-to-day activities of QA DSM team. Additionally, this role participates in improvement initiatives and supports regulatory agency and third-party inspections.

 

What You'll Do

 

• Manages daily QA operations, including batch review, release processes, and validation activities, ensuring alignment with organizational and regulatory standards

• Provides leadership in quality and regulatory oversight for the DSM program• Builds and leads the QA Operations Team during the project phase• Leads the QA effort for the development of documents, processes, and procedures for the DSM program• Assesses the impact of system and process modifications and maintains change control• Reviews and approves system and process lifecycle documentation, including risk and impact assessments, specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports• Generates, reviews, and approves QA procedures for validation approaches and lifecycle documents for Manufacturing and IT Computerized Systems• Generates, reviews, and approves QA documentation, procedures, and processes to support manufacturing operations in a Current Good Manufacturing Practice (CGMP) regulated facility• Ensures consistent high standards in equipment and process validation to meet quality objectives on time• Provides QA oversight for maintaining the validated state of Manufacturing Systems during commercial operations• Manages, leads, develops, and mentors QA DSM team while overseeing, organizing, and coordinating the tasks within the department• Develops, measures and reports team KPIs in support of site and departmental goals• Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to ensure quality standards• Adapts responsibilities as the project group expands and transitions into operations• Participates in periodic international and domestic travel, as required• Performs other duties, as assigned

 

Minimum Requirements:

 

• Bachelor’s degree in engineering or related science degree with 7+ years of experience in a GMP environment OR• Master’s degree in engineering or related science degree with 5+ years of experience in a GMP environment OR• Ph.D. with 4+ years of experience in a GMP environment• 2-5 years of years of Management experience

• Experience in ownership and/or approval of deviations, CAPAs and change controls, and batch record review• Experience with GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11/Annex11• Experience with cell culture or fermentation processes, formulation/fill, and/or finished goods manufa