Global Quality E-Learning Project Manager

Position Overview Power how FUJIFILM Biotechnologies learns, performs, and passes inspections. As the Global Quality E‑Learning Project Manager, you will be the global specialist for designing and producing compliant, high‑impact digital learning that serves every site and function. As an Articulate 360 superuser, you’ll turn complex GMP concepts into engaging, measurable learning at scale—harmonizing standards, strengthening inspection readiness, and helping our teams deliver right‑first‑time 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Why this role matters Elevate performance at scale: Your modules will train thousands across Manufacturing, QC, MSAT, Supply Chain, EHS, and Quality—directly improving training compliance, right‑first‑time execution, and inspection readiness. Be the quality bar: You’ll set global e‑learning standards, templates, and practices that drive consistency, reduce rework, and accelerate deployment across sites and through high quality, professionalism, and motivating, inspiring design. Connect people, process, and systems: Partnering with the LMS Project Manager and the Global Learning BPO, and externally with local site SMEs, you’ll ensure content is validated, LMS‑ready, and fully aligned to the QMS/EDMS—so training stays synchronized with controlled procedures. What you’ll do: - Produce cross‑site e‑learning modules - Translate complex GMP concepts, SOP changes, and procedural workflows into clear learning objectives, storyboards, and assessments mapped to role‑based curricula and risk/criticality. - Design, develop, and publish high‑impact modules in Articulate 360 (Storyline/Rise) using SCORM 1.2/2004 and/or xAPI; incorporate simulations, branching scenarios, and performance‑based checks to drive behavior change. - Apply instructional design best practices (ADDIE), adult learning theory, cognitive load management, and accessibility standards (e.g., WCAG 2.1 AA: alt text, color contrast, keyboard navigation, transcripts/captions). - Produce or source multimedia (voiceover, motion graphics, screen captures), maintain brand compliance, and ensure multilingual readiness (externalized text, localization templates). - Execute quality controls (functional/device/browser testing, quiz logic validation), maintain validation evidence (URS/Design Spec, Trace Matrix, UAT), and prepare release documentation aligned to change control. - Plan and manage multiple concurrent builds with defined scope, timelines, resources, risks/mitigations; provide weekly status updates. - Define measurable acceptance criteria (e.g., assessment reliability, completion time, satisfaction scores, error‑free LMS runtime) and hand over administrator playbooks for deployment. Cross‑site stakeholder coordination - Run structured intake with SMEs/BPOs to capture learning needs, target audiences, prerequisites, and outcomes; align on scope, success metrics, and review cadence. - Facilitate iterative reviews (alpha/beta/final) with Quality, Manufacturing, QC, MSAT, EHS, and site C&LD to ensure technical accuracy, alignment with approved procedures, and inspection readiness. - Resolve feedback conflicts using decision criteria (risk to compliance, clarity, learner burden, time‑to‑release), escalating to sponsors/GBPO as needed. - Coordinate formal approvals; maintain audit‑ready records (comment logs, version histories, approvals, change requests) and keep training content synchronized with controlled source documents. - Communicate proactively across time zones; publish plans, milestones, and change impacts to minimize rework and deployment delays. Standards and superuser enablement - Define and maintain global e‑learning standards: content templates, interaction patterns, question banks, accessibility checklists, media/narration guidelines, metadata schema, and publishing presets. - Establish naming conventions and taxonomies to support findability, reusability, and consistent reporting across sites and languages. - Create and maintain production playbooks and style guides (storyboard templates, asset management, voiceover specs); deliver enablement sessions for site content creators. - Provide tier‑2 support for Articulate 360 and related tools (troubleshooting, performance optimization, runtime issues) and recommend upgrades, plug‑ins, or workflow automations. - Monitor adherence to standards via periodic reviews; report deviations, propose corrective actions, and update standards based on lessons learned and regulatory expectations. LMS integration and release - Package courses with appropriate SCORM/xAPI settings (completion/score, mastery score, resume behavior), apply standardized metadata (title, version, language, tags, source SOP/change number), and verify tracking fields. - Execute pre‑release checks (pilot enrollments, data capture validation, accessibility verification), document UAT results, and obtain release approvals under change control. - Ensure robust version control and traceability to QMS/EDMS sources; coordinate retirements and archiving of superseded content to prevent training drift. - Provide hypercare support post‑release (issue triage, quick fixes, analytics verification) and confirm stabilization criteria. Continuous improvement and community of practice - Track effectiveness metrics (quiz item analysis, completion/overdue trends, time‑on‑task, error/Deviation trends linked to trained procedures) and learner feedback; prioritize and implement improvements. - Pilot innovations (microlearning refreshers, just‑in‑time job aids, scenario‑based assessments, translation workflows, AI‑assisted narration where permitted) and evaluate impact on learning and compliance. - Contribute to a Global Community of Practice: share templates, exemplars, and retrospectives; host clinics; mentor site developers; maintain a living repository of best practices. - Benchmark external practices (industry forums, regulatory trends) to keep the e‑learning ecosystem current, scalable, and inspection‑ready. - And other job duties as assigned. Minimum qualification requirements - Bachelor’s degree required in Instructional Design, Education/Adult Learning, Communications/Media, Life Sciences, or related field with 5 years of progressive hands‑on e‑learning development; OR Master’s degree required in Instructional Design, Education/Adult Learning, Communications/Media, Life Sciences, or related field with 3 years of progressive hands‑on e‑learning development experience. - 4+ years in learning/e‑learning within a GxP biotechnology/pharmaceutical environment. - Demonstrated experience producing enterprise‑scale modules, including storyboarding, media production, and SCORM/xAPI packaging. - Strong understanding of GMP/GDP training requirements, 21 CFR Part 11/EU Annex 11 considerations for training records, and alignment to QMS/EDMS content. - Familiarity with LMS integration and reporting. Preferred requirements - Development using Articulate 360 at superuser level strongly preferred. - Portfolio of completed modules strongly preferred. What you’ll bring to thrive - Expert proficiency with Articulate 360 (Storyline, Rise, Review, 360 Suite), media editing tools, and SCORM 1.2/2004 and xAPI. - Understanding of GxP expectations for training content traceability, data integrity (ALCOA+), accessibility, and validation documentation. - Working knowledge of LMS workflows, curriculum mapping, and EDMS/QMS linkages (e.g., change control). - Advanced instructional design, needs analysis, storyboarding, and assessment design. - Project management, stakeholder facilitation, and concise technical communication. - Strong visual design/UX sensibilities; attention to detail; ability to manage multiple concurrent builds. - Data‑driven improvement using learner analytics, quiz performance, and survey feedback. Role details - Global scope; outputs serve all sites and functions. - Travel up to 10% domestic/international; prolonged computer/design work; ability to lead virtual workshops and reviews. - 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 GMP safety compliance. Your impact from day one - Deliver compelling, inspiring learning that measurably improves qualification, reduces late/overdue training, and strengthens audit readiness. - Establish one global standard for e‑learning quality—accelerating adoption, enabling consistent reporting, and reducing rework. - Help teams perform with confidence—turning procedures into practice and practice into outcomes for patients and clients. Ready to build a world‑class e‑learning ecosystem that powers quality across a global network? Apply now to become the Company’s Global Quality E‑Learning Project Manager. This is a global position that will support all our FUJIFILM Biotechnologies sites. 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 ([email protected]).