Sr. Gxp Training

**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.

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

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 (Qual