Senior Manager, Compliance Manufacturing

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

The Senior Manager, Compliance Manufacturing will 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.

Company Overview

At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

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.

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

Job Description

What You'll Do:

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).


• Updates to leadership.


• 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.

Minimum Education & Experience 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.


• 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.

EEO Information

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.

ADA Information

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 ([e-mail]).