Sr. GxP Training & Learning Manager

The Senior GxP Training & Learning Manager is a strategic leadership role responsible for designing implementing and governing a globally compliant GxP learning and knowledge management framework. Positioned at the intersection of Quality Assurance Regulatory Affairs and Operations this role ensures that all learning systems processes and content support inspection readiness regulatory alignment (such as FDA EMA ICH) and a culture of continuous improvement.

This leader will oversee the integration of validated Learning Management Systems (LMS) coordinate cross-functional training programs and establish quality-driven learning pathways tailored to evolving global standards and risk profiles.

Develop and Drive Enterprise-Wide GxP Training Strategy

• Design and lead a scalable risk-based GxP training strategy aligned with global regulatory requirements (e.g. Eudralex Vol. 4 EU GMP Annex 1 Annex 11 Annex 13 Annex 16 PIC/S ICH10 21 CFR Part 11 ICH E6/E8 WHO Technical Report Series) internal policies and quality objectives.
• Ensure global training programs support the new hire onboarding ongoing development and procedural change management across departments including TechOps RDMA and Affiliates GxP related functions.
• Establish and manage certification programs for critical GxP roles (e.g. deviation impact assessors change control impact assessors root cause investigators internal auditors) ensuring personnel are qualified to perform these high- impact tasks.

Oversee Learning Management System (LMS) Optimization (Veeva Business Admin for Training)

• Manage the lifecycle configuration validation and continuous improvement of the LMS to ensure compliance scalability and audit readiness.
• Govern LMS analytics to monitor learner engagement ensure data integrity and maintain traceability of training records
• Integrate certification tracking within the LMS to ensure real-time visibility of personnel qualifications for critical GxP processes.
• Manage daily operations for training and learning management including document training distribution via LMS liaison person for Quality Training Coordinator role Assess LMS system change impact on GxP quality processes.

Ensure Regulatory Compliance and Inspection Readiness

• Serve as the subject matter expert (SME) for GxP training during health authority inspections and internal/external audits ensuring training records curricula and effectiveness metrics are defensible and audit-ready.
• Lead internal training audits and provide strategic oversight on training-related CAPAs deviations and procedural updates to ensure timely and compliant execution.
• Evaluate the impact of non-conformances (NCs) on GxP quality processes and compliance within the scope of training management investigations leading root cause investigations and corrective actions for training-related compliance gaps.
• Ensure GxP refresher trainings are designed implemented and managed at least on a yearly basis covering regulatory requirement and current business needs topics (e.g. data integrity QMS processes as deviation management complaint handling). Coordinate Cross-Functional Training Needs and Curriculum Development
• Conduct training needs assessments and develop tailored curricula across functional areas including TechOps and RDMA GxP related functions.
• Collaborate with functional leaders to align training programs with GxP principles fostering accountability upskilling and cross-functional alignment (TechOps RDMA and Affiliates). Maintain a robust certification program for internal auditors ensuring they are trained and qualified to conduct audits in alignment with GxP principles. Develop and Monitor Training Effectiveness Metrics
• Establish and track key performance indicators (KPIs) and metrics to evaluate training effectiveness ensure timely completion and drive continuous improvement initiatives.
• Use data-driven insights to enhance training programs and ensure alignment with quality and compliance objectives.
• Monitor certification completion rates and re-certification timelines to ensure personnel remain qualified for critical GxP roles. Integrate Knowledge Management Initiatives
• Lead efforts to capture structure and disseminate operational knowledge across the organization to reduce errors align teams and accelerate decision-making. Manage Vendor Relationships and External Training Providers
• Oversee vendor relationships to ensure external training content meets regulatory standards and business needs.
• Evaluate and integrate external training solutions to complement internal programs. Foster a Culture of Compliance and Professional Growth
• Mentor and manage QTC (Quality Training Coordinators) role promoting a culture of compliance learning and professional development.
• Collaborate with cross-functional leaders to embed GxP principles into the organizational culture and drive continuous improvement.
• Promote the value of certification programs as a tool for professional growth and operational excellence ensuring employees are motivated to achieve and maintain certifications.

Qualifications :

Education/Learning Experience/Work Experience

• 10 years of experience in the pharmaceutical biotechnology or medical device industry with a strong focus on GxP compliance quality systems or training management.
• 5 years of leadership experience in designing and managing GxP training programs including LMS implementation and optimization.
• Proven track record in managing certification programs for critical GxP roles such as deviation impact assessors change control assessors root cause investigators and internal auditors.
• Experience in regulatory inspections (e.g. FDA EMA WHO) as a training SME with demonstrated success in defending training programs and records during audits.
• Hands-on experience with Learning Management Systems (LMS) including configuration validation and analytics (e.g. Veeva Vault SAP SuccessFactors or similar platforms).

Skills/Knowledge/Languages

• Deep knowledge of global regulatory requirements for GxP compliance
• Expertise in GMP GDP GCP and GVP principles with the ability to translate regulatory requirements into effective training programs.
• Strong understanding of quality management systems (QMS) including CAPA management change control and deviation handling.
• Proficiency in developing and tracking KPIs and metrics to measure training effectiveness and compliance.
• Familiarity with certification frameworks for GxP roles including program design implementation and re-certification processes
• Proven experience with eQMS LMS and DMS platforms (with a preference for Veeva vaults).
• Certified GxP Professional (CGxP) Certified Training and Development Professional (CTDP) or equivalent certification in training program management (desirable)
• Fluent in English Personal Attributes

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Full-time