QA Compliance Lead: Quality Risk & Recalls

Sarepta Therapeutics; Bedford (MA); Hybrid; USD 136,000 - 170,000; Full time

Benefits offered by this job

Physical & emotional wellness

Financial wellness

Caregiver support

Job summary

Sarepta Therapeutics seeks a Sr. Manager, QA Compliance to drive GMP/GxP quality systems and data-driven improvement. You will partner across QA operations, QC, manufacturing, MS&T, and external vendors to trend product data and address adverse trends.

You’ll own Product Complaints and the Product Recall process while ensuring regulatory readiness. Ideal candidates bring US/ EU GMP knowledge, strong communication, and a proven ability to lead cross‑functional initiatives in a fast-paced

Qualifications

• B.S./B.A. in Life Science or related field; 10 years pharma/biopharmaceutical QA experience
• 5+ years hands-on QA/Quality Engineering with increasing responsibility
• GMP experience with commercial products, global exposure
• Extensive knowledge of US GxP and EU GMP requirements
• Experience with regulatory inspections (FDA/EU) and QA oversight

Responsibilities

• Track and close Quality Records (deviations, investigations, CAPA) with SMEs
• Maintain Quality Metrics and KPIs for trending
• Lead quarterly/annual trending of quality records and escalation
• Monitor and report quality record trends to reduce non-conformances

Skills

Quality Assurance

GxP Compliance

FDA/EU inspections

Risk management

CAPA

Quality Records

Quality Metrics

Cross-functional

QMS (Veeva)

Document management

GMP

Education

Bachelor's degree in Life Science

Tools

Veeva QMS

Job description

Sarepta Therapeutics seeks a Sr. Manager, QA Compliance to drive GMP/GxP quality systems and data-driven improvement. You will partner across QA operations, QC, manufacturing, MS&T, and external vendors to trend product data and address adverse trends.

You’ll own Product Complaints and the Product Recall process while ensuring regulatory readiness. Ideal candidates bring US/ EU GMP knowledge, strong communication, and a proven ability to lead cross‑functional initiatives in a fast-paced