The Manager of Compliance & Support, DP develops and oversees the manufacturing support team within the drug product scope. This position ensures compliance by addressing and closing gaps, authoring departmental standard operating procedures (SOPs), creating master batch records in electronic systems managing the production scheduler, batch record reviewers, manufacturing execution systems associates, and training coordinators. The role also supports shop floor activities for deviations, corrective and preventive actions (CAPAs), and aids in materials management for production operations.

FUJIFILM 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

• Builds and manages the Manufacturing Support team
• Supervises the Manufacturing Support team and establish individual and team goals
• Oversees and coordinates team tasks, including managing the production scheduler
• Fosters an inclusive culture with development plans and regular meetings
• Coaches and supports team members for professional growth
• Acts as lead for regulatory inspections and audits
• Coordinates non-batch activities, own change controls, and manage Corrective Actions Preventative Actions within Trackwise
• Leads continuous improvement initiatives
• Manages batch record review and cycle time Key Performance Indicators
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs other duties, as assigned

Basic Requirements

• High School Diploma or GED with 11+ years of experience from a similar role in large pharma/biotech operations or projects OR
• Associate degree in Pharmaceutical Sciences, Life Sciences, or a related field with 9+ years of direct experience OR
• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, or related field with 7+ years of direct drug product manufacturing experience OR
• Equivalent military experience or training
• Up to 2 years of people management experience
• Experience working in a regulated GMP environment

Preferred Requirements

• 2-5 years of people management experience
• Experience in aseptic drug product manufacturing, cross-functional collaboration, sterile processing, or quality assurance

• Bioworks or BTEC Coursework

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• 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
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds

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).