Investigation Team Lead - Deviations & CAPA

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Healthcare benefits

Retirement plan

Paid time off

Well-being resources

Career development

Flexible work

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Manager, Resilience (Drug Product Finished Goods) to lead a high-impact investigations function. You will mentor 4–8 direct reports, drive timely, data-driven resolutions to major events, and serve as a visible leader during inspections, while promoting a continuous improvement and people-first culture.

The role emphasizes collaboration across DPFG, Manufacturing Support, Quality, and Operations, with a focus on CAPA development, regulatory

Qualifications

• Bachelor's degree with 6+ years in life sciences or regulated industries; or
• Master's degree with 4+ years in life sciences or regulated industries.
• Experience managing and developing people.
• Experience with regulatory inspections, investigations, and change management.
• 2-3 years leading investigations or an investigations team.

Responsibilities

• Lead, manage, and build the investigations team, including hiring and development.
• Ensure training on investigational and root-cause tools for GMP readiness.
• Oversee deviation management transfer and local stand-up.
• Lead investigations and ensure timely, high-quality closures.

Skills

Leadership

GMP knowledge

Regulatory inspections

Root cause analysis

Project management

Education

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

High school diploma + 10 years

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Manager, Resilience (Drug Product Finished Goods) to lead a high-impact investigations function. You will mentor 4–8 direct reports, drive timely, data-driven resolutions to major events, and serve as a visible leader during inspections, while promoting a continuous improvement and people-first culture.

The role emphasizes collaboration across DPFG, Manufacturing Support, Quality, and Operations, with a focus on CAPA development, regulatory