Sr. GxP Training & Learning Manager

Company Description

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Job Description

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

· Excellent communication, facilitation, and interpersonal skills (encourages open dialogue and ensures alignment across functional teams).

· Ability to lead cross-functional and -cultural teams in a matrixed organization.

· Articulates complex regulatory and compliance concepts clearly and persuasively to diverse audiences. · Sets ambitious goals and inspires teams to challenge the status quo.

· Encourages innovation and curiosity to drive continuous improvement in training programs and compliance initiatives.

· Takes bold and decisive actions, assuming full responsibility for outcomes.

· Builds strong, respectful relationships across departments and with external stakeholders.

· Promotes teamwork and cooperation to achieve shared goals, recognizing that collaboration is key to success.

· Acts professionally, respects different viewpoints, and promotes an inclusive environment.

Additional Information

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