Senior Manager, R&D Training System & Operations

Responsibilities:
- Co-manage Sarepta’s global GxP Training Program; maintain compliance and inspection readiness.
- Manage and operate the validated Veeva Training Vault LMS; ensure accuracy/compliance of governing SOPs.
- Serve as primary R&D training SME/point of contact.
- Ensure personnel qualification across GLP, GCLP, GCP, GVP, GRP, and GPP.
- Own training procedures, materials, and tools; ensure they are compliant, scalable, and fit for purpose.
- Provide new-hire QMS training and annual GxP refresher training.
- Design training (e.g., CBT, microlearning, eLearning) using tools such as Articulate Storyline and/or Adobe Captivate.
- Manage onboarding/offboarding/LOA/return-to-work training assignments and due dates.
- Oversee train-the-trainer and on-the-job training for critical operations impacting product quality/patient safety.
- Maintain qualification records; review policies and assign “read and understand” training.
- Generate training reports/dashboards; perform LMS health checks (KPI metrics, trending, escalation/mitigation).
- Support LMS enhancements/upgrades (testing/validation) and cross-functional coverage.

Qualifications/Skills:
- BS+ in a scientific discipline (preferred).
- 7–9 years R&D training management experience (required).
- Strong GLP (21 CFR Part 58) and GCP (ICH E6(R2)) expertise; additional GVP/GRP expertise.
- Advanced Veeva Training (Quality Vault) experience (required).
- Strong MS Office skills.
- Ability to work independently, communicate effectively, influence/negotiation, and drive continuous improvement.

Benefits (high level): Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.

Application instructions:
- Candidates should apply; candidates must be authorized to work in the U.S.