Why this role matters
- You will drive training harmonization for how FLBG trains personnel guiding a forward-looking model that is both compliant and future proof.
- Your roadmap will shape our maturity and scalability across the network reducing compliance risk coordinating a common roadmap informed by local input and global direction to support network maturity and scalability and decrease compliance risk.
- Youll lead a global Community of Practice that translates strategy into actionaligning site leaders and process owners behind one harmonized standard.
What youll do
Own and maintain the end-to-end global training process and documents
- Author and control global SOPs work instructions templates and forms in compliance with FDA EMA MHRA ICH and applicable GMP/GDP/GCP expectations.
- Ensure integration with QMS elements (Document Control Deviation/CAPA Change Control Validation Data Integrity and Electronic Systems/LMS).
- Define standard role-based curricula and training effectiveness approaches for network deployment.
Execute strategic direction and conduct regulatory intelligence
- Scan and interpret regulatory trends and inspection observations relevant to training and data integrity; embed requirements into process design.
- Establish a 23-year roadmap for training-process maturity digital enablement and scalability.
- Provide guidance on risk-based training and qualification strategies for specialized GMP roles (e.g. aseptic operations cleanroom fermentation/bioreactor analytical QC).
Cascade and enable deployment across the network
- Lead and coach Local Process Owners (site Training BPOs) on translating the global process into site procedures and LMS configurations.
- Build and facilitate a Global Community of Practice to align practices share lessons learned and standardize change adoption.
- Deliver toolkits playbooks and training content to drive consistent implementation and change management.
Drive transparency performance and continuous improvement
- Define and publish global KPIs/KQIs (e.g. training on-time completion effectiveness checks critical-role qualification right-first-time documentation).
- Lead cross-site problem-solving; analyze data trends; prioritize remediation and CI initiatives to reduce late/overdue training and improve inspection readiness.
- Benchmark industry practices and leverage digital features of the LMS and connected QMS.
Governance deliverables and audit/inspection support
- Achieve roadmap milestones (e.g. Global Training Process SOP release global curricula aligned for common roles standardized qualification matrices).
- Represent the training process in customer and health authority inspections; coordinate responses and sustainable CAPAs for training-related findings.
- Participate in cross-functional governance forums to align with Manufacturing QC MSAT Supply Chain EHS P&C and IT/CSV.
And other job duties as assigned.
Minimum qualifications:
- Bachelors degree in Life Sciences Quality/Regulatory Learning & Development Industrial/Organizational Psychology Engineering or related field with 8 years of progressive experience in GxP training/learning Quality Systems or process ownership within biopharmaceutical biologics vaccines or CDMO environments; OR
- Masters degree in Life Sciences Quality/Regulatory Learning & Development Industrial/Organizational Psychology Engineering or related field with 6 years of progressive experience in GxP training/learning Quality Systems or process ownership within biopharmaceutical biologics vaccines or CDMO environments.
And:
- Demonstrated experience leading cross-site or enterprise process deployments and managing controlled documents in a regulated environment.
- Strong knowledge of FDA EMA MHRA and ICH guidelines; direct participation in regulatory inspections and client audits strongly preferred.
- General understanding of GMP operations including manufacturing and QC laboratory contexts.
- Experience with electronic LMS and integrated QMS platforms; data analytics for KPI/KQI reporting.
- Experience facilitating training and workshops.
Or:
- Any combination of education and experience which would provide an equivalent background to deliver against role expectations.
Preferred requirements
- Masters degree preferred.
What youll bring to thrive
- Technical knowledge: GxP regulations relevant to GMP training and data integrity (FDA 21 CFR Parts 210/211/11 EU GMP MHRA guidance ICH Q-series); LMS/QMS administration concepts; electronic signatures/ALCOA; validation/CSV considerations; role-based curricula design; fundamentals of GMP manufacturing across modalities aseptic behaviors cleanroom practices contamination control and QC workflows.
- Skills and capabilities: Advanced process design and documentation; project/program and change management; strong analytical skills with KPI/KQI definition dashboarding and insights-to-action; excellent written and verbal communication with senior/executive stakeholders; facilitation of cross-site communities; problem solving conflict resolution and indirect/matrix leadership; ability to maintain confidentiality and composure during inspections and escalations.
Role details
- Locations: US UK or Denmark with global scope across all company sites and business units.
- Travel: Up to 10% domestic and international.
- Work environment: Prolonged screen time; ability to manage multiple concurrent projects and deadlines across regions; adherence to EHS quality data privacy/security and data integrity policies. Site visits may require PPE and compliance with GMP and safety procedures.
Your impact from day one
- Establish and enforce one global training standard that connects people process and technology.
- Improve inspection readiness and employee qualification across the networkreducing remediation protecting revenue and reputation and accelerating delivery for clients and patients.
- Mobilize a global community to scale best practices fast turning data into decisions and decisions into measurable outcomes.
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.
Job Location:
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
