Senior Manager, Compliance Manufacturing

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

About the role

Lead the design, execution, and continuous improvement of the company’s compliance program. Oversee risk assessments, policies and controls, monitoring and testing, investigations, training, reporting, and regulatory engagement. Manage a team of compliance professionals and partner with business leaders to embed a culture of compliance and ethical conduct.

• Management scope: Manages a team of professionals; may manage managers.
• Impact: Department or multi-function impact; sets tactical plans aligned to business strategy.
• Autonomy: Operates with limited guidance; responsible for budget, resource planning, and outcomes.

Responsibilities

• Program Leadership
  • Own the compliance program framework, annual plan, and multi-year roadmap; align with regulatory expectations and business strategy.
  • Define compliance policies, standards, and procedures; drive adoption across regions/functions.
• Risk Assessment and Controls
  • Lead periodic enterprise and functional compliance risk assessments; maintain risk registers.
  • Design and implement controls; coordinate with Internal Audit and Risk on testing and remediation.
• Monitoring, Testing, and Reporting
  • Build risk-based monitoring and testing plans; track issues through closure.
  • Establish KPIs/KRIs; deliver dashboards and reports to executive leadership and the board/committee.
• Investigations and Incident Management
  • Oversee intake (hotline, reports) and triage; lead or coordinate investigations; ensure timely corrective actions.
  • Manage regulatory inquiries, exams, and responses in partnership with Legal.
• Training and Culture
  • Develop role-based training and communications; measure effectiveness and completion.
  • Champion ethical culture and speak-up environment.
• Third-Party and Product/Change Compliance
  • Oversee third-party risk and due diligence for high-risk vendors and intermediaries.
  • Review new products, markets, and business changes for compliance impact; advise on requirements.
• Data, Privacy, and Recordkeeping
  • Ensure adherence to data protection, record retention, and reporting obligations (tailor to GDPR/CCPA/industry as applicable).
• Team Leadership and Operations
  • Hire, coach, and develop the compliance team; set goals and performance standards.
  • Manage budget, tools, and technology (case management, GRC platforms, training LMS).
  • Provide updates to leadership.

Requirements

• Bachelor’s degree required; JD, MBA, or relevant Master’s preferred depending on industry.
• 8–12+ years in compliance, legal, audit, or risk; 3–5+ years managing teams.
• Certifications (as applicable): CCEP, CRCM, CAMS, CIPP/E/US, CIPM, ICA, or equivalent.
• Industry-specific experience:
  • Financial services/insurance: AML/BSA, sanctions, conduct risk, sales practices, complaints, market conduct, model governance.
  • Tech/SaaS: privacy, data governance, AI/ML risk, platform integrity, export controls.
  • Life sciences: anti-bribery/anti-corruption (ABAC), interactions with HCPs, promotional compliance.

Physical Requirements

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time - up to 60 minutes.
• Ability to sit for prolonged periods of time - up to 60 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 33 lbs.
• 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 - up to 2-8 degrees C.