Global GxP Learning Project Manager

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 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 network—initiatives 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 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. Ready to lead programs that shape how a global CDMO learns and performs? Apply now to become FLBG’s 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 processes personal data relating to job applicants. The organization is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring 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 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 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 (). Originally posted on Himalayas