Deviation Supervisor

Fujifilm • Holly Springs, NC

16h

About The Position

The Deviation Supervisor leads a high-impact manufacturing support team responsible for keeping production safe, compliant, reliable, and on schedule. The role oversees materials, training, and production scheduling support teams and reports to the Manager, Manufacturing Support. It supervises approximately 4–8 professional and skilled contributors and partners with manufacturing, quality, supply chain, and other functions in a fast-paced, project-driven environment.

During the project phase, the supervisor leads operational-readiness work to establish GMP-compliant processes, build the manufacturing support documentation and recipe-driven operations team, and oversee commissioning activities for support functions. In operations, the supervisor develops team members and oversees campaign materials, Kanban and vendor-managed inventory support, training readiness, batch schedules, short flow investigations, alert and action limits, change controls, and CAPAs. The role also drives continuous improvement, mitigates manufacturing risks, and provides secondary leadership for regulatory inspections and audits.

The position requires flexibility to support a 24/7 manufacturing facility and travel domestically and internationally up to 25% during the project phase and operations. The work environment may include warm or cold settings and outdoor work, and may involve operating machinery or power tools and moving objects weighing 10–33 lbs.

Requirements

• High school diploma or GED with 6 years of related experience; or a bachelor's degree in Life Science, Engineering, or a related field with 2 years of related experience; or a master's degree in Life Science, Engineering, or a related field with no prior experience.
• Experience directly supporting manufacturing.
• Experience with regulatory inspections, investigations, and change management.
• Experience in pharmaceutical or biological manufacturing operations.
• Flexibility to support a 24/7 manufacturing facility.
• Ability to travel domestically and internationally up to 25% during the project phase and operations.
• Advanced understanding of GMPs, inspection readiness, safety, and manufacturing operations.
• Strong collaboration skills with manufacturing and cross-functional stakeholders.
• Excellent organizational skills and project management capabilities.
• Proven ability to coach, lead, and develop individual contributors.
• Strong presentation and communication skills.
• Ability to champion continuous improvement practices and ideas.

Nice To Haves

• Experience leading others in a pharmaceutical or biological manufacturing facility.
• Experience working in a changing environment within a project-driven organization.
• Lean certification or similar certifications.

Responsibilities

• Lead operational-readiness initiatives to ensure GMP readiness.
• Create or transfer business processes from an existing large-scale facility.
• Establish and lead the manufacturing support documentation and recipe-driven operations team.
• Oversee commissioning activities for support functions and ensure alignment with GMP standards.
• Manage and develop direct reports across materials, training, and production scheduling support teams through coaching and guidance.
• Address performance gaps and employee concerns, partnering with HR as needed.
• Participate in recruiting and retention activities as needed.
• Oversee day-to-day manufacturing support, including campaign materials, Kanban, and 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 affecting employees, including time off, shift work, and inclement weather.
• Complete administrative responsibilities, including timecard and time-off approvals and expense reports.
• Perform other duties as assigned.

Benefits

• Competitive pay with performance-aligned incentives.
• Comprehensive health benefits, including medical, dental, and vision.
• Employee assistance resources.
• Retirement savings plan with company support.
• Paid time off, holidays, and leave programs.
• Professional development and leadership training opportunities.
• Inclusive culture that values safety, integrity, and continuous improvement.
• Flexible support for a 24/7 operation, with resources to help balance work and life.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED