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Deviation Supervisor

FujiFilm
7 hours ago
On-site
Holly Springs, NC, United States
Indeed

Position Overview Lead a high-impact team that keeps manufacturing running smoothly, safely, and on schedule. As Supervisor, Deviation, you’ll oversee materials, training, and production scheduling teams to ensure compliant, reliable operations. If you’re a people-focused leader who thrives in dynamic environments and enjoys building processes and teams from the ground up, this role is for you. 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 About Us We are a 24/7 manufacturing organization committed to operational excellence, safety, and compliance. This role sits within the Manufacturing function and reports to the Manager, Manufacturing Support. You’ll supervise a team of professional and skilled support contributors (approximately 4–8 direct reports), partnering closely with manufacturing, quality, supply chain, and other functions. Our environment is project-driven and fast-paced, with opportunities to shape and scale best-in-class Good Manufacturing Practice (GMP) processes. Responsibilities During the Project Phase Lead operational readiness initiatives to ensure GMP readiness: Create or transfer business processes from an existing large-scale facility. Stand up and lead the manufacturing support documentation and recipe-driven operations team. Provide oversight of commissioning activities for support functions and ensure alignment with GMP standards. Administer company policies affecting employees (e.g., time off, shift work, inclement weather). Complete administrative responsibilities (e.g., timecard approvals, time off approvals, expense reports). Perform other duties, as assigned. In Operations Manage and develop direct reports across materials, training, and production scheduling support teams: Provide coaching and guidance to foster growth and performance. Address performance gaps and employee concerns; partner with HR as needed. Participate in recruiting and retention to attract and retain talent, as needed. Oversee day-to-day support for manufacturing: Coordinate campaign materials, Kanban, vendor-managed inventory support. Oversee training curricula and readiness. Manage detailed batch schedules and short flow investigations. Monitor and maintain alert and action limits. Lead and manage change controls and corrective and preventive actions (CAPAs). Drive continuous improvement, escalate issues appropriately, and mitigate manufacturing risks. Support and act as a secondary lead for regulatory inspections and audits. Administer company policies impacting employees (e.g., time off, shift work, inclement weather). Complete administrative responsibilities (e.g., timecard approvals, time off approvals, expense reports). Perform other duties, as assigned. Minimum Qualifications (Must-Haves) High School diploma/GED with 6 years related experience; or Bachelor&rs…

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