Manager, Deviations Management

Position Overview

Lead a high-impact investigations team that safeguards product quality and patient trust. As Manager Resilience (Drug Product Finished Goods) youll 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 inspectionsall 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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: 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 resiliencepartnering across manufacturing quality and support teams to meet critical timelines without compromising quality.
• Youll report to the Senior Director DPFG lead a growing team (approximately 48 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
  • Bachelors degree with 6 years in life sciences pharmaceuticals or regulated industries; or
  • Masters 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.
• 23 years of experience leading investigations or an investigations team.

Preferred Qualifications

• 610 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 roles purpose we encourage you to applyeven if your experience doesnt align with every preferred qualification. Accommodations are available upon request during the recruitment process.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto 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 ().

Required Experience:

Manager