Job Description
Job Overview:
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. 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:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
The Sr. Manager, GxP Training position is responsible to co-manage Sarepta’s global GxP Training Program. The position will reside partially on-site in the Andover, MA site and partially remote in a hybrid capacity, reporting to the Director of Global GxP Quality Systems within the quality organization.The position encompasses a variety of training management responsibilities, including maintaining a compliant GxP Training Program in accordance with US and International guidelines and regulatory requirements; maintaining a validated electronic learning management system (Veeva Training Vault); owning training SOPs and materials within area of responsibility; designing and delivering quality/regulatory compliance related training to personnel; collaborating with functional areas to identify and training roles/curricula assignments; and ultimately ensuring the training program is fit for use and functioning in a healthy/compliant state. This Sr. Manager, GxP Training will also serve as the training expert and primary point of contact for all corporate wide training needs specific to the following GxP areas of practice:
• Good Clinical Practice (GCP)
• Good Clinical Laboratory Practice (GCLP)
• Good Pharmacovigilance Practice (GVP)
• Good Regulatory Practice (GRP)
This role will work closely with Quality Systems personnel and to ensure sustained compliance across Sarepta’s global Quality Management System.
The Opportunity to Make a Difference
- Ensure compliance with global regulations and Sarepta’s Training Policy; own and maintain internal training SOPs and related content ensuring it’s compliant, fit for purpose, and scalable for continuous improvement/ongoing growth.
- Serve as the primary GCP/GCLP/GVP/GRP training subject matter expert and primary point of contact.
- Collaborate cross functionally with R&D functional area management to ensure training matrices (role-based training, curriculum, training requirements, and employee assignments) are properly managed and maintained.
- Design training (CBT courses, microlearning videos, training materials, OJT criteria, etc.) and deliver training on pertinent GCP/GCLP/GVP/GRP regulations, topics, and related business operations.
- Work in partnership with the Sr. Manager, GxP Training (GMP/GDisP) to ensure full alignment on training operations and ways of working amongst R&D and Technical Operation organizations, including critical training programs (i.e., trainer qualification, OJT program, training needs analysis, etc.).
- Provide corporate wide/QA training support, as needed, to the GLP training team located at Sarepta’s Gene Therapy Center of Excellence (GTCOE) site in Columbus, OH.
- Manage annual curricula reviews with R&D functional area management; GxP refresher training; and new hire QMS training.
- Utilize and support a validated training LMS application (Veeva Training Vault) and support end use. Work with the Quality Systems team to continuously improve and maintain Sarepta’s GxP Training LMS.
- Ensure training assignments and methods of delivery are effective regardless of the person’s existing knowledge level; perform periodic assessments on the health status of the system and escalate issues to QA leadership, when appropriate.
- Verify KPI results are complete and accurate based on internal performance targets. Work with training liaisons and department management to drive on-time training completion and ongoing compliance.
- Provide cross functional / back up support to other team members to ensure ample daily coverage.
- 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.
- Minimum 10 years’ experience in a similar training management position within the life sciences industry required.
- Strong foundational expertise of GCP regulations and ICH E6(R2) required; additional GCLP/GLP/GVP/GRP regulatory compliance training experience a plus.
- Experience designing and delivering training on pertinent GxP (GCP/GCLP/GVP/GRP) regulations and related subject matter, including the creation of eLearning materials utilizing Articulate Storyline and/or Adobe Captivate software required.
- Experience utilizing an electronic Training Learning Management System required, preferably Veeva Training Vault.
- 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, with minimal oversight and SME involvement.
- Superb communication, presentation skills, and adult learning techniques across all levels of an organization and utilizing modern tools and training strategies.
- 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.
