Senior Manager, R&D Training System & Operations

Sarepta Therapeutics•Remote Massachusetts, MA

20d•$136,000 - $170,000•Remote

About The Position

The Senior Manager, R&D Training System and Operations co-manages Sarepta’s global GxP Training Program. This is a remote role requiring occasional travel to Massachusetts and Ohio sites a few times a year for collaboration and regulatory inspection support. As a working leader, this role balances hands-on operational execution with strategic program management. Key responsibilities include maintaining a compliant global GxP training program, managing the validated Veeva Training Vault LMS, and ensuring the accuracy and compliance of all governing SOPs. The position directly ensures that global personnel are properly qualified to perform their roles across various compliance areas.

Requirements

Bachelor’s Degree or higher in a scientific discipline preferred.
7-9 years of experience in a similar R&D training management role within the life sciences industry required.
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 is required.
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 required.
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.
Candidates must be authorized to work in the U.S.

Responsibilities

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.