Hybrid QA Compliance Leader – Risk & Recalls

Sarepta Therapeutics; Andover (MA); On-site; USD 136,000 - 170,000; Full time

Job summary

The Sr. Manager, QA Compliance at Sarepta Therapeutics leads quality systems to ensure product quality across manufacturing and testing. You will partner with QA, manufacturing, MS&T, and vendors to monitor data, trends, and continuous improvement.

You will own the Product Recall process and oversee deviations, CAPA, and change controls, ensuring regulatory readiness and risk mitigation. This hybrid role requires strong communication and compliance expertise.

Qualifications

• B.S. or B.A. in Life Science with 10 years' pharmaceutical/biopharmaceutical QA experience, including 5–10 years in QA/Quality Engineering.
• Extensive GMP knowledge (US/EU) and experience in Product Complaints, CAPA, deviations, change controls.
• Excellent communication, cross-functional collaboration, and ability to work under pressure.

Responsibilities

• Track and manage Quality Records across deviations, investigations, change controls, complaints, and CAPA.
• Maintain Quality Metrics and KPIs for trending programs.
• Lead quarterly/annual trending of quality records and report to the Quality Review Board.
• Provide QA oversight for risk assessments per ICH Q9 and GMP.
• Support regulatory inspections, submissions, and internal/external audits.
• Own Product Recall process and escalation of quality defects.
• Document management: author/review GMP controlled documents.

Skills

GxP quality systems

Quality Assurance

Regulatory compliance

Cross-functional collaboration

Auditing

Quality metrics

FDA/EU inspection experience

Education

B.S. or B.A. in Life Science/Health Science/Biology

Tools

Veeva GMP QMS

Job description

The Sr. Manager, QA Compliance at Sarepta Therapeutics leads quality systems to ensure product quality across manufacturing and testing. You will partner with QA, manufacturing, MS&T, and vendors to monitor data, trends, and continuous improvement.

You will own the Product Recall process and oversee deviations, CAPA, and change controls, ensuring regulatory readiness and risk mitigation. This hybrid role requires strong communication and compliance expertise.