Manager, QA Drug Substance
Are you a skilled leader ready to drive impactful change in Quality Assurance? As the Manager, QA Drug Substance, you will use your leadership skills to optimize processes and form strategic partnerships with CQV and Engineering teams. Your ability to lead and inspire teams will be crucial in enhancing quality standards during both the project phase and operations.
During the project phase, your focus will be on spearheading quality oversight for Drug Substance Manufacturing processes and managing validation documentation to ensure the highest standards are met. This role requires collaboration across various project areas and QA departments to effectively harmonize strategies and procedures.
As operations commence, you will lead Quality partnerships, guaranteeing DSM systems and processes are operated and maintained in a validated state throughout their lifecycle. Your leadership will ensure consistent policy administration and provide QA oversight of the day-to-day activities of the QA DSM team. Additionally, you will drive improvement initiatives and support regulatory agency and third-party inspections.
This position offers a unique opportunity to work on a CAPEX project and seamlessly transition into Operations, allowing you to make a significant contribution to a dynamic and innovative environment. Join us to shape the future of quality management in our organization.
FUJIFILM Diosynth Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers
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 manufacturing
Preferred Requirements:
• Experience and knowledge of ASTM E2500,
• Lean Six Sigma or continuous improvement methodologies
• Quality Risk Management principles
• Smartsheet and/or Kneat validation software
Physical and Work Environment Requirements:
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 240 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
Ability to operate machinery and/or power tools.
Ability to conduct work that includes moving objects up to 33 pounds.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
Will work in warm/cold environments, 5C.
Will work in heights greater than 4 feet.
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.
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
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