GMP Deviation Lead - 24/7 Manufacturing Ops

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive pay

Comprehensive health benefits

Retirement plan

Paid time off

Professional development

Inclusive culture

24/7 operation support

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Supervisor, Deviation to lead a multi-functional team ensuring GMP readiness and compliant production schedules. You will oversee materials, training, and scheduling in a 24/7 environment, guiding process improvements and robust change management.

The role emphasizes leadership, cross-functional collaboration, and a strong track record in regulated biopharma manufacturing. Travel up to 25% may be required during project phases.

Qualifications

• High school diploma or GED with 6 years related experience; or
• Bachelor's Degree in Life Science, Engineering, or related field with 2 years related experience; or
• Master's Degree in Life Science, Engineering, or related field with no prior experience

Responsibilities

• Lead operational readiness initiatives to ensure GMP readiness and stand up the manufacturing support documentation team.
• Oversee commissioning activities for support functions and ensure alignment with GMP standards.
• Manage day-to-day manufacturing support including materials, training, and schedule coordination.

Skills

GMP knowledge

Leadership

Project management

Regulatory inspections

Cross-functional collaboration

Communication

Education

Bachelor's Degree in Life Science or Engineering

Master's Degree in Life Science or Engineering

Tools

LEAN certification

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Supervisor, Deviation to lead a multi-functional team ensuring GMP readiness and compliant production schedules. You will oversee materials, training, and scheduling in a 24/7 environment, guiding process improvements and robust change management.

The role emphasizes leadership, cross-functional collaboration, and a strong track record in regulated biopharma manufacturing. Travel up to 25% may be required during project phases.