Manager, Compliance & Support, Drug Product

Position Overview The Manager of Compliance & Support, DP develops and oversees the manufacturing support team within the drug product scope. This position ensurescompliance by addressing and closing gaps, authoring departmental standard operating procedures (SOPs), creating master batch records in electronicsystems managing the production scheduler, batch record reviewers, manufacturing execution systems associates, and training coordinators. The role alsosupports 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, weu2019ll open North Americau2019s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. Weu2019re 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 weu2019re proud to cultivate a culture that will fuel your purpose, energy, and driveu2014what we call Genki. Ready to shape the future of medicine? Letu2019s transform healthcare together Holly Springs, North Carolina, combines small-town warmth with proximity to Raleighu2019s 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 u201cgiving our world more smiles.u201d Visit: Job Description What Youu2019ll Do u2022 Builds and manages the Manufacturing Support team u2022 Supervises the Manufacturing Support team and establish individual and team goals u2022 Oversees and coordinates team tasks, including managing the production scheduler u2022 Fosters an inclusive culture with development plans and regular meetings u2022 Coaches and supports team members for professional growth u2022 Acts as lead for regulatory inspections and audits u2022 Coordinates non-batch activities, own change controls, and manage Corrective Actions Preventative Actions within Trackwise u2022 Leads continuous improvement initiatives u2022 Manages batch record review and cycle time Key Performance Indicators u2022 Administers company policies such as time off, shift work, and inclement weather that directly impact employees u2022 Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.) u2022 Coaches and guides direct reports to foster professional development u2022 Participates in the recruitment process and retention strategies to attract and retain talent, as needed u2022 Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution u2022 Performs other duties, as assigned Basic Requirements u2022 High School Diploma or GED with 11+ years of experience from asimilar role in large pharma/biotech operations or projects OR u2022 Associate degree in Pharmaceutical Sciences, Life Sciences, or arelated field with 9+ years of direct experience OR u2022 Bacheloru2019s degree in Pharmaceutical Sciences, Life Sciences, orrelated field with 7+ years of direct drug product manufacturingexperience OR u2022 Equivalent military experience or training u2022 Up to 2 years of people management experience u2022 Experience working in a regulated GMP environment Preferred Requirements u2022 2-5 years of people management experience u2022 Experience in aseptic drug product manufacturing, cross-functionalcollaboration, sterile processing, or quality assurance u2022 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._ 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 (). Job Locations _US-NC-Holly Springs_ Posted Date _3 weeks ago_ _(11/10/2025 12:30 PM)_ _Requisition ID_ _2025-35842_ _Category_ _Manufacturing_ _Company (Portal Searching)_ _FUJIFILM Biotechnologies_

Created: 2025-12-04