Manufacturing Compliance Leader: Strategy, Risk & Training

FUJIFILM Biotechnologies; Milwaukee (WI); On-site; USD 150,000 - 210,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Senior Manager, Compliance Manufacturing to design, execute, and continually improve the company’s compliance program. You will lead risk assessments, policies, controls, monitoring, investigations, training, and reporting while partnering with business leaders to embed an ethical culture.

The role requires managing a team of compliance professionals and coordinating with Legal on regulatory inquiries, exams, and responses, with a focus on cross-functional

Qualifications

• 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.
• 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.

Responsibilities

• Own the compliance program framework, annual plan, and multi-year roadmap; align with regulatory expectations and business strategy.
• 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.
• 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.
• Oversee intake (hotline, reports) and triage; lead or coordinate investigations; ensure timely corrective actions.
• Manage regulatory inquiries, exams, and responses in partnership with Legal.
• Develop role-based training and communications; measure effectiveness and completion.
• 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.
• Ensure adherence to data protection, record retention, and reporting obligations (tailor to GDPR/CCPA/industry as applicable).
• Hire, coach, and develop the compliance team; set goals and performance standards.
• Manage budget, tools, and technology (case management, GRC platforms, training LMS).
• Updates to leadership.

Skills

Compliance program design

Risk assessments

Policies and controls

Monitoring and testing

Investigations

Training and culture

Regulatory engagement

Team leadership

Education

Bachelor's degree required; JD, MBA, or relevant Master's preferred

Tools

GRC platforms

Case management tools

Job description

FUJIFILM Biotechnologies is seeking a Senior Manager, Compliance Manufacturing to design, execute, and continually improve the company’s compliance program. You will lead risk assessments, policies, controls, monitoring, investigations, training, and reporting while partnering with business leaders to embed an ethical culture.

The role requires managing a team of compliance professionals and coordinating with Legal on regulatory inquiries, exams, and responses, with a focus on cross-functional