Position OverviewLead 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.
Job DescriptionAbout 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.
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 place. 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.
