Investigations & Deviation Manager, GMP Resilience

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

Benefits offered by this job

Healthcare coverage (medical, dental,‑

Retirement savings plan with company 


Paid time off

Paid parental leave

Well-being resources

Mentorship and training opportunities

Flexible work practices

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Manager, Resilience (Drug Product Finished Goods) to lead a high-impact investigations team, ensuring timely, high-quality resolutions and quality during inspections. Reporting to the Senior Director, DPFG, you’ll mentor 4–8 direct reports and partner across Manufacturing Support, Quality, and Operations.

You will drive continuous improvement, CAPA effectiveness, and on-time closures, while fostering a people-first culture and top-tier

Qualifications

• Education and experience options as listed: HS diploma/GED with 10 years in life sciences/pharma; Bachelor’s with 6 years; Master’s with 4 years.
• Experience managing, leading, and developing people.
• Experience with regulatory inspections, investigations, and change management.
• Knowledge of root cause analysis tools.
• 2–3 years of experience leading investigations or an investigations team.

Responsibilities

• Lead, manage, and build the investigations team, including hiring and onboarding.
• Ensure the team is trained on investigational and root-cause tools.
• Transfer and stand up deviation management process from a sister site locally.
• Administer company policies impacting employees.
• Lead investigations during regulatory inspections and audits.
• Foster an inclusive, people-first culture with development plans.

Skills

Leadership

Project management

Cross-functional collaboration

Coaching & development

GMP knowledge

Education

High school diploma or GED

Bachelor’s degree in life sciences or related

Master’s degree in life sciences or related

Tools

CAPA tools

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Manager, Resilience (Drug Product Finished Goods) to lead a high-impact investigations team, ensuring timely, high-quality resolutions and quality during inspections. Reporting to the Senior Director, DPFG, you’ll mentor 4–8 direct reports and partner across Manufacturing Support, Quality, and Operations.

You will drive continuous improvement, CAPA effectiveness, and on-time closures, while fostering a people-first culture and top-tier