Teams at Sarepta Therapeutics

Lead and execute GPV and GLP/GCLP vendor audits, develop audit plans and reports, review vendor responses, support GxP inspections, maintain audit schedules and records, and revise GxP quality documentation to ensure regulatory compliance.

Lead development of commercial field training strategy and capabilities, create and deliver scientific, product, and disease-state education, ensure promotional review/MLR compliance, implement virtual and in-person training delivery (national/regional), measure training impact, and collaborate cross-functionally to meet business needs.

Lead end-to-end process development for oligonucleotide and siRNA therapies from preclinical through commercialization. Define phase-appropriate strategies, scale-up, tech transfer, CDMO oversight, and QbD-aligned control strategies. Provide technical and regulatory support for CMC documentation, investigations, and validation readiness while collaborating across functions to enable clinical and commercial manufacturing.