Why this role matters
- Accelerate site readiness: Your programs underpin start-ups tech transfers and scale-upsreducing risk avoiding delays and enabling on-time batch release.
- Harmonize how we train: Youll 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 youll turn procedures into practicemeasurably improving qualification and inspection readiness.
What youll 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 and support 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 ELearning 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
- Bachelors degree required in Life Sciences Education/Instructional Design Information Systems Quality/Regulatory or related field with 5 years of progressive experience managing medium-to-large learning/training projects with formal charters and sponsors in regulated biotechnology/pharmaceutical/CDMO environments; OR
- Masters degree required in Life Sciences Education/Instructional Design Information Systems Quality/Regulatory or related field with 3 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
- Masters degree strongly preferred.
- Formal project management training/certification (e.g. PMP PRINCE2 Agile/Scrum) preferred.
What youll 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 linkages (document control change control deviation/CAPA) and their impact on training assignments.
- 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.
Role scope and impact
- Global scope across all company sites; own delivery of assigned global learning projects within sponsor and governance frameworks.
- Accountable for project outcomes stakeholder alignment LMS readiness and sustainable adoption; no direct budget authority but manage projects within approved budgets and timelines.
- Coordinate with Global Quality/L&D site leadership and enabling functions (IT/CSV P&C EHS Communications).
- High impact on training across the networkinitiatives often underpin site start-ups tech transfers and scale-ups. Failure to deliver may result in inspection observations delayed batch release remediation costs and client risk.
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 globallyenabling 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.
Ready to lead programs that shape how a global CDMO learns and performs Apply now to become FLBGs Global Quality Digital Learning Project Manager.
This is a global position that will support all our FUJIFILM Biotechnologies sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.
As part of any recruitment process FUJIFILM Biotechnologies collects and processespersonal data relating to job applicants. Theorganizationis committed to beingtransparent about how it collects and usesthat data and to meeting its data protection obligations and may share this as part of the global recruitment process withhiring managers in Europe and the United States.
To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agenciesto 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 agencieswere 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 agencyengagement process is hired no fee or payment of any kind will be paid.
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