Manager, Deviations Management

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

Position Overview

Lead a high-impact investigations team that safeguards product quality and patient trust. As Manager, Resilience (Drug Product Finished Goods), you'll build and mentor a best-in-class investigations function, drive timely and high-quality resolutions to major and critical events, and be a visible leader during inspections-all while fostering a continuous improvement and people-first culture.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

About Us

• We operate at the forefront of pharmaceutical/biological manufacturing, with a mission to deliver safe, effective products at scale.
• Our Drug Product Finished Goods (DPFG) organization thrives on collaboration, operational excellence, and resilience-partnering across manufacturing, quality, and support teams to meet critical timelines without compromising quality.
• You'll report to the Senior Director, DPFG, lead a growing team (approximately 4-8 direct reports), and work cross-functionally with leaders across Manufacturing Support, Quality, and Operations.

Responsibilities During the project phase

• Lead, manage, and build the investigations team, including hiring, onboarding, and capability development.
• Ensure the team is trained on investigational and root-cause tools to be fully ready for GMP operations.
• Transfer and stand up the deviation management process from a sister site while building out the function locally.
• Administer company policies that directly impact employees.
• Complete administrative tasks (e.g., timecard approvals, time-off approvals, expense reports).
• Perform other duties, as assigned.

In operations

• Manage, lead, develop, and mentor a team of investigators; organize and coordinate daily/weekly workloads and priorities.
• Ensure on-time closure of investigations while maintaining high-quality, data-driven investigation standards.
• Serve as the primary manufacturing contact for customers on investigation management, specific investigations, and status updates.
• Drive continuous improvement by holding the team accountable for creating effective CAPAs and validating CAPA effectiveness.
• Partner cross-functionally with Manufacturing Support leaders to identify, train, and maintain an auxiliary pool of competent investigators to ensure on-time, high-quality closures.
• Track and report resilience and manufacturing support compliance metrics and KPIs, including on-time CAPA closures and effectiveness checks.
• Act as investigations lead during regulatory inspections and audits; effectively communicate results and recommendations.
• Foster an inclusive, people-first culture through meaningful development plans, regular 1:1s, and skip-level 1:1s on a defined cadence.
• Complete administrative tasks (e.g., timecard approvals, time-off approvals, expense reports).
• Perform other duties, as assigned.

Minimum Qualifications

• Education and experience (one of the following):
  • High school diploma or GED with 10 years in life sciences, pharmaceuticals, or regulated industries; or
  • Bachelor's degree with 6 years in life sciences, pharmaceuticals, or regulated industries; or
  • Master's degree with 4 years in life sciences, pharmaceuticals, or regulated industries.
• Prior experience managing, leading, and developing people.
• Experience with regulatory inspections, investigations, and change management.
• Knowledge and experience with root cause analysis tools.
• 2-3 years of experience leading investigations or an investigations team.

Preferred Qualifications

• 6-10 years' experience in pharmaceutical/biological manufacturing operations.
• Previous experience leading others in a pharmaceutical/biological manufacturing facility.
• Experience working in a changing, project-driven organization.
• Lean certification or similar continuous improvement certification.

Knowledge, Skills, and Abilities

• Strong collaboration skills across manufacturing and cross-functional teams.
• Excellent organizational and project management capabilities; able to prioritize and deliver under tight timelines.
• Champion for continuous improvement with a track record of driving effective CAPAs.
• Advanced understanding of GMP, inspection requirements, safety, and manufacturing operations.
• Proven ability to coach, lead, and develop individual contributors.

Benefits

• Comprehensive healthcare coverage (medical, dental, vision) for you and eligible dependents.
• Retirement savings plan with company match.
• Paid time off, company holidays, and paid parental leave.
• Employee well-being resources, including mental health and family support programs.
• Professional development opportunities, mentorship, and access to training/certifications.
• Inclusive, people-first culture with clear growth pathways and performance feedback.
• Flexible work practices where role-appropriate and business needs allow.

Inclusion Statement

• We value diverse perspectives and experiences. If you meet the minimum qualifications and are excited by this role's purpose, we encourage you to apply-even if your experience doesn't align with every preferred qualification. Accommodations are available upon request during the recruitment process.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).