Senior Quality Audit Leader (Hybrid)

Sarepta Therapeutics; Bedford (MA); Híbrido; USD 136.000 - 170.000; Jornada completa

Descripción de la vacante

Sarepta Therapeutics is seeking a Sr. Manager, Corporate Quality Audits to provide GxP oversight for vendor management and audits.

You will lead GPV/GLP/GCLP audits, ensure compliance with FDA, ICH, OECD, and global requirements, and drive continuous quality improvements across the supplier base. Across the role you will support the integration of acquired programs, maintain audit schedules, and serve as a QA contact for vendor-related decisions.

Formación

• Bachelor's degree in Life Sciences with 8+ years in pharmaceutical or biotech drug development.
• Minimum 5 years of experience in GPV and GLP/GCLP auditing.
• Extensive experience with OECD GLP/GPV, ICH E6 GCP, FDA and EU requirements.
• Excellent interpersonal skills and ability to work cross-functionally.
• Travel domestically and internationally up to 20%.

Responsabilidades

• Conduct GPV and GLP/GCLP external audits of Sarepta approved vendors.
• Develop audit plans, perform quality audits, prepare reports, and communicate results.
• Audit qualification of new vendors and perform for-cause audits as needed.
• Review vendor audit responses against industry standards to ensure controls.
• Serve as QA point of contact for vendor audits, oversight, and compliance decisions.
• Maintain annual external audit schedules as requested.
• Provide support during GXP health authority inspections.
• Revise and create GxP quality documentation and templates.
• Manage auditing files, licenses, and certificates for the vendor program.
• Assume additional duties as assigned.

Conocimientos

Interpersonal skills

Willingness to travel

Educación

Bachelor's degree in Life Sciences

Advanced degree preferred

Descripción del empleo

Sarepta Therapeutics is seeking a Sr. Manager, Corporate Quality Audits to provide GxP oversight for vendor management and audits.

You will lead GPV/GLP/GCLP audits, ensure compliance with FDA, ICH, OECD, and global requirements, and drive continuous quality improvements across the supplier base. Across the role you will support the integration of acquired programs, maintain audit schedules, and serve as a QA contact for vendor-related decisions.