[Hiring] Global GxP Learning Project Manager @Fujifilm

Role Description

Power the way FUJIFILM Biotechnologies learns—at scale. As our Global GxP Digital Learning Project Manager, you will lead cross-site, chartered programs that elevate training effectiveness, harmonize curricula, and ensure inspection-ready learning across a growing global CDMO. You’ll bring structure, pace, and precision to initiatives like new LMS transformation, AI-enabled training tools, global training-matrix harmonization, and learning effectiveness frameworks—so our workforce is qualified, compliant, and ready to deliver for patients and clients worldwide.

What you’ll do

• Cross-site project management:
  • Lead chartered global learning projects end-to-end (initiation through hypercare).
  • Establish scope, success metrics, milestones, RAID logs, and stakeholder communications.
  • Coordinate cross-functional teams (Quality, Manufacturing, QC, MSAT, EHS, HR, IT/CSV) across time zones.
  • Chair governance forums; manage vendors as applicable.
  • Guide validation-aligned project deliverables (URS/requirements, design specs, test plans, UAT evidence, change control records) where required.
  • Track budget, timeline, and outcomes against charter; escalate risks and decisions to sponsors.
  • Ensure project closure with benefits realization and lessons learned.
• Training program and curriculum at global scale:
  • Harmonize program structures across sites to enable consistent compliance reporting and mobility of talent.
  • Define retraining rules, equivalencies, and effectiveness checks.
  • Ensure traceability from controlled source documents (QMS/EDMS) into training content and assignments.
• Digital learning design and launch:
  • Coordinate production and deployment of digital learning assets (e-learning, video, microlearning, job aids) within the project.
  • Align with brand, accessibility (WCAG 2.1 AA), and data integrity (ALCOA+) standards.
  • Collaborate with the E‑Learning and Video SMEs to leverage templates, interaction patterns, and AI-enabled tooling where appropriate.
  • Oversee packaging (SCORM/xAPI), UAT in validated LMS environments, and cutover/hypercare plans to minimize disruption.
• Process improvement:
  • Identify systemic opportunities to improve training processes and LMS utilization.
  • Implement CI initiatives with measurable targets (cycle-time reduction, overdue reduction, data quality improvement).
  • Update standards and playbooks accordingly.
• Administrative tasks:
  • Perform administrative duties and other job tasks as assigned.
  • And other job duties that may be assigned from time to time (within total allocation).

Qualifications

• Bachelor’s degree required in Life Sciences, Education/Instructional Design, Information Systems, Quality/Regulatory, or related field with 8 years of progressive experience managing medium-to-large learning/training projects with formal charters and sponsors in regulated biotechnology/pharmaceutical/CDMO environments; OR
• Master’s degree required in Life Sciences, Education/Instructional Design, Information Systems, Quality/Regulatory, or related field with 6 years of progressive experience managing medium-to-large learning/training projects with formal charters and sponsors in regulated biotechnology/pharmaceutical/CDMO environments.
• 4+ years in learning within a GxP biotechnology/pharmaceutical environment.
• Proven experience coordinating cross-site stakeholders and deploying solutions in validated LMS environments; familiarity with EDMS/QMS integrations (e.g., Veeva, MasterControl).
• Working knowledge of GxP training requirements, 21 CFR Part 11 and EU Annex 11 for records/e-signatures, and inspection-readiness practices.
• Experience with digital learning design and tools (e.g., Articulate 360, video/microlearning, SCORM/xAPI); ability to drive quality and accessibility.

Preferred requirements

• Master’s degree strongly preferred.
• Formal project management training/certification (e.g., PMP, PRINCE2, Agile/Scrum) preferred.

What you’ll bring to thrive

• Knowledge: GxP training frameworks, data integrity (ALCOA+), inspection-readiness principles; familiarity with FDA, EMA, and MHRA expectations.
• Skills and capabilities: Project/program management, stakeholder management, and change management across time zones and cultures.
• Instructional design literacy with the ability to scope and quality-assure digital learning deliverables.
• Analytical acumen for KPI/KQI development, dashboarding, and benefits realization.
• Clear written and verbal communication with senior stakeholders.
• Matrix leadership, conflict resolution, and problem solving under deadline.

Work environment

• Prolonged screen time; ability to facilitate virtual workshops, governance meetings, and audits.
• Ability to travel domestically and internationally up to 10%.
• Ability to manage multiple concurrent projects and deadlines across regions/time zones.
• Adherence to EHS, quality, data privacy/security, and data integrity policies; site visits may require PPE and adherence to GMP and safety procedures.

Your impact from day one

• Deliver enterprise-ready digital learning programs that harmonize standards, reduce overdue training, and uplift inspection readiness.
• Create role-based curricula and qualification strategies that scale globally—enabling consistent compliance and faster time-to-competence.
• Partner across Quality, Operations, IT/CSV, and HR to turn training strategy into measurable outcomes for clients and patients.

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 ([email protected]).