Deviation Supervisor

Fujifilm • Holly Springs, NC

1d • Onsite

About The Position

The Deviation Supervisor leads a high-impact manufacturing support team responsible for materials, training, and production scheduling, helping maintain safe, compliant, reliable, and on-schedule operations. The role is part of the Manufacturing function 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.

During the project phase, the supervisor leads operational readiness initiatives to establish GMP-ready processes, including creating or transferring business processes from an existing large-scale facility, standing up a documentation and recipe-driven operations team, and overseeing commissioning activities for support functions. In operations, the supervisor develops direct reports and oversees manufacturing support activities, including campaign materials, training readiness, detailed batch scheduling, investigations, change controls, CAPAs, and continuous improvement. The role also supports regulatory inspections and audits and handles employee policy and administrative responsibilities.

The organization is a 24/7 manufacturing operation with a fast-paced, project-driven environment and opportunities to shape and scale GMP processes. The position requires flexibility to support the facility and the ability to travel domestically and internationally up to 25% during the project phase and operations.

Requirements

• High school diploma/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.
• 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.
• Coach and guide employees to foster growth and performance.
• Address performance gaps and employee concerns, partnering with HR as needed.
• Participate in recruiting and retention activities as needed.
• Coordinate 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 employee policies, including those related to time off, shift work, and inclement weather.
• Complete administrative duties such as timecard approvals, 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 coverage, and 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