Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
Position Overview Summary:
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 the following compliance areas:
• Good Laboratory Practice (GLP)
• Good Clinical Laboratory Practice (GCLP)
• Good Clinical Practice (GCP)
• Good Pharmacovigilance Practice (GVP)
• Good Regulatory Practice (GRP)
• Good Pharmacoepidemiology Practice (GPP)
The Opportunity to Make a Difference
- 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.
More about You
- 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.
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Onsite
This position requires work on site at one of Sarepta’s facilities in the United States.
The targeted salary range for this position is $136,000 - $170,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
