Note: The job is a remote job and is open to candidates in USA. Sarepta Therapeutics is at the forefront of genetic medicine, particularly in Duchenne muscular dystrophy, and is looking for a Senior Manager for their R&D Training System and Operations. This role co-manages the global GxP Training Program, ensuring compliance and operational excellence in training processes across the organization.
Responsibilities
- Maintain a compliant global GxP training program
- Manage the validated Veeva Training Vault LMS
- Ensure the accuracy and compliance of all governing SOPs
- Ensure compliance with global regulations and Sarepta’s Training Policy
- Own and maintain training procedures, materials, and tools, ensuring they are compliant, fit for purpose, and scalable for ongoing growth
- Serve as the primary R&D training subject matter expert (SME) and point of contact, ensuring the training system and operations are always inspection ready
- Work in partnership with Corporate Compliance-Quality Systems Team to ensure training processes are fit for purpose and identify/drive continuous improvement
- Collaborate cross functionally with R&D functional area management to ensure training matrices (role-based training, curriculum, training requirements, and employee assignments) are properly established and maintained
- Provide new hire QMS training and annual GxP refresher training for personnel
- Design training courses, as needed (i.e., CBT courses, microlearning videos, training materials) – utilizing training design software applications and tools
- Perform onboarding, offboarding, leave of absence and return of absence activities to effectively manage training assignments and due dates
- Utilize and perform daily training operations utilizing Sarepta’s training LMS application (Veeva Training Vault) and provide daily end user support
- Oversee training programs, including train-the-trainer and on-the-job training of critical operations having direct product quality and/or patient safety impact
- Maintain employee qualification records, including job descriptions and curricula vitae documentation, assuring training requirements align with personnel responsibilities
- Review Sarepta policies and procedures and assign read and understand training accordingly
- Generate training reports and dashboards, as needed
- Perform training system health check assessments, KPI metrics, trending, escalation, and mitigation, when possible
- Support training LMS enhancements and routine upgrades, including the testing/validation to ensure the system meets intended use
- Provide cross-functional support to other team members to ensure ample daily coverage is provided across the organization
- Participate in team/company initiatives in support of achieving Sarepta’s objectives and quality goals
Skills
- 7-9 years of experience in a similar R&D training management role within the life sciences industry
- Strong foundational expertise of GLP (21 CFR Part 58), GCP regulations and ICH E6(R2); additional GVP and GRP regulatory training expertise
- Advanced knowledge utilizing an electronic Training Learning Management System – Veeva Training within the Quality Vault
- Experience designing and delivering GxP training on GCP/GCLP/GLP/GVP/GRP related subject matter, including the creation of eLearning materials utilizing Articulate Storyline and/or Adobe Captivate software
- Strong computer skills utilizing MS Office Products (i.e., MS Word, Excel & PowerPoint); advanced working knowledge preferred
- Change agent personality; identifies continuous improvement opportunities and drives innovation across the GxP training system
- Strong team player with demonstrated track record of success in a cross‐functional team and fast-acting environment
- Ability to work independently, as needed, requires minimal SME involvement when compiling content for custom GxP training materials
- Excellent organizational, computing and oral/written communication skills
- Ability to influence and negotiate effective solutions
- Strong critical thinking and decision-making skills
- Bachelor's Degree or higher in a scientific discipline
Benefits
- Remote role requiring occasional travel to Massachusetts and Ohio sites a few times a year for collaboration and regulatory inspection support
- For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Company Overview