Job
Core
Design, implement, and govern GxP training programs to ensure employee qualification and inspection readiness in a pharmaceutical CDMO.
Role type
Senior Training Scientist, Quality Systems & Validation
Builds
GxP training frameworks, role-based curricula, and qualification pathways
Domain
Pharmaceutical manufacturing / Quality Systems
Required skills
GxP regulatory knowledge, Quality Management Systems (QMS), training program design, risk-based training effectiveness measurement, audit support, stakeholder collaboration
Preferred skills
Experience translating SOPs into training, continuous improvement methodologies
Technologies
GxP, QMS, SOPs
Responsibilities
Develop and maintain compliant GxP training programs; Design role-based training curricula and matrices; Create onboarding pathways for GxP roles; Align training with regulatory requirements and SOPs; Measure training effectiveness using risk-based methods; Support internal and external audits and regulatory inspections; Lead training activities for deviations, CAPAs, and change controls
Seniority
Senior, hands-on IC