Primary Responsibilities Include:

• Conduct GMP external audits of Sarepta approved vendors including Contract Manufacturers, APIs, Drug Product, Primary and Secondary Packaging, Contract Laboratories, 3PL and transport vendors. Develop audit plan, conduct quality audit, prepare audit reports and communicate and escalate findings, including compliance risk. Recommends approval or disapproval of vendors based on compliance assessment.
• Review and evaluate vendors audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet quality requirements.
• Assist in the maintenance of the annual internal and external audit schedules as requested by management.
• Conduct for cause audits of external vendors as requested by management.
• Conduct Quality Audits associated with qualification of new vendors.
• Conduct internal audits of Sarepta GxP sites and facilities. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings, including compliance risk.
• Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.
• Manage gap assessment audits and Regulatory readiness inspections at Sarepta facilities as needed.
• Manage the Vendor Change Notification Program.
• Participate in Regulatory inspections at Sarepta facilities and/or entities.
• Prepare metrics and reports of auditing activities and submit for Management Review.
• Manage Sarepta's Approved Vendor Management program as applicable to all current and new vendors. Perform vendor performance assessment.
• Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete required audit tasks.
• Manage auditing files, records, reports, licenses and certificates associated with the approved vendor program.
• Assumes additional duties and responsibilities as assigned.

Desired Education and Skills:

• Bachelor's Degree required in a scientific discipline required.
• Minimum 7 years' experience in a regulated industry required; in a Quality Auditing role preferred.
• Other requirements include Excellent organizational skills; ability to work independently and in team environments.
• Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.
• Understanding of GMP/GDP compliance requirements; understanding of FDA and Global GMP Quality Requirements.
• Must demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities/assignments.
• Must demonstrate effective communication skills and technical writing ability.
• Must be able to travel domestically and/or internationally 20% of the time.

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.

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.