Manager, Compliance & Support, Drug Product

Fujifilm•Holly Springs, NC

22d

About The Position

Position Overview 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. Company Overview 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 Job Description What You’ll Do

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
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

Nice To Haves

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

Responsibilities

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