Associate Director, Drug Substance Ops & Compliance

FUJIFILM; Holly Springs (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina seeks an Associate Director, DSM to lead a defined operations area, align teams, and ensure cGMP, regulatory readiness, and budget targets are met. You will develop frontline leaders, drive performance, and coordinate cross-functional priorities in a dynamic, project-driven environment.

You will manage KPIs, implement improvements, and foster safety and inclusion while partnering with Quality, Engineering, Supply Chain, and Process Sciences to deliver

Qualifications

• Bachelor’s degree (BA/BS) in a related field and 8+ years of biotech/pharma experience, including prior people leadership (managing and developing teams).
• BA/BS in Life Sciences or Engineering; or Master’s degree with 6+ years in a similar role within large pharma/biotech.
• 6–10 years in pharmaceutical/biological manufacturing operations.
• Experience leading leaders (managers/supervisors) in a changing, project-driven environment.
• Direct experience with regulatory inspections, investigations, change control, KPIs, and operational budgeting.

Responsibilities

• Lead area operations to achieve production goals with rigorous execution, right-first-time performance, and schedule adherence.
• Translate site objectives into clear goals; communicate vision across multiple levels and ensure alignment with Quality, Engineering, Supply Chain, and Process Sciences.
• Own area KPIs and budget; track performance, forecast needs, and implement corrective and preventive actions to meet targets.
• Govern process changes and documentation to maintain cGMP compliance; champion inspection readiness and lead regulatory inspections for the function.
• Develop supervisors and associate managers; build succession pipelines, coach performance, and foster a culture of safety, inclusion, and continuous improvement.
• Partner with support groups to remove bottlenecks, resolve deviations, drive investigations, and implement change management effectively.
• Represent Manufacturing in client interactions; support day-to-day coordination, scope discussions, and progress reviews.
• Execute other duties as assigned to support a dynamic, project-driven operation.

Skills

People leadership

Regulatory inspections

Cross-functional collaboration

Budget management

Process improvement

Education

Bachelor’s degree in related field

Master’s degree (preferred)

Job description

FUJIFILM Biotechnologies in North Carolina seeks an Associate Director, DSM to lead a defined operations area, align teams, and ensure cGMP, regulatory readiness, and budget targets are met. You will develop frontline leaders, drive performance, and coordinate cross-functional priorities in a dynamic, project-driven environment.

You will manage KPIs, implement improvements, and foster safety and inclusion while partnering with Quality, Engineering, Supply Chain, and Process Sciences to deliver