The Importance of the Role

The Sr. Manager, Corporate Quality Audits, provides GxP oversight for the vendor management and audit program, with primary responsibility for GPV and GLP/GCLP vendor audits. The role ensures compliance with FDA, ICH, OECD, and other global requirements, supports the integration of acquired programs, and drives continuous improvement of quality systems.

The Opportunity to Make a Difference

Primary responsibilities include:

·Conduct GPV and GLP/GCLP external audits of Sarepta approved vendors. Develop audit plans, conduct quality audits, prepare audit reports, and communicate and escalate findings, including compliance risk.

·Conduct Quality Audits associated with qualification of new vendors.

·Conduct for cause audits of external vendors as requested by management.

·Review and evaluate vendors audit response against current industry standards and guidelines to ensure sufficient controls are in place by the supplier to meet quality requirements.

·Serve as a QA point of contact for vendor-related audits, performance oversight, and compliance decision-making.

·Assist in the maintenance of the annual external audit schedules as requested by management.

·Provie support during GXP health authority inspections

·Revise and create GxP quality documentation, including SOPs, policies, templates, and work instructions.

·Manage auditing files, records, reports, licenses and certificates associated with the approved vendor program.

·Assumes additional duties and responsibilities as assigned.

More about You

Assumes additional duties and responsibilities as assigned.

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-Hybrid

#LI-ES1

This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.

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.