Global GxP Learning Project Manager

About this role

Position Overview
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.
Company Overview
The work we do at FUJIFILM Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Biotechnologies and help make the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki. 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:
Job Description
Why this role matters

• Accelerate site readiness: Your programs underpin start-ups, tech transfers, and scale-ups—reducing risk, avoiding delays, and enabling on-time batch release.

• Harmonize how we train: You’ll align curricula, rules, and reporting across sites, creating a single, global way of working for training that strengthens compliance and mobility of talent.

• Connect people, process, and platforms: By integrating QMS/EDMS, LMS, and digital learning, you’ll turn procedures into practice—measurably improving qualification and inspection readiness.

• Reduce inspection and operational risk: Embed compliance-by-design through governance, standardized methods, and data-driven effectiveness.

What you’ll do
Cross-site project management

• Lead chartered global learning projects end-to-end (initiation through hypercare), establishing 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 (e.g., metadata standards, curriculum taxonomies, effectiveness analytics, change impact assessments).

• 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).

Minimum qualification requirements

• 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. LMS administration concepts (curricula, metadata, equivalencies, retraining), interoperability (SCORM/xAPI), and validation basics (CSV). EDMS/QMS…