QA Compliance Senior Manager: GMP, Recalls & Risk

Socket.dev; Andover (MA); On-site; USD 136,000 - 170,000; Full time

Benefits offered by this job

Hybrid work model

Equal Opportunity Employer

Job summary

Sarepta Therapeutics is seeking a Sr. Manager, QA Compliance to lead quality systems across manufacturing, QC and MS&T. You will collaborate cross-functionally to trend data, manage recalls, and support regulatory activities for Sarepta’s commercial products.

The role requires strong GMP experience, independent judgment, and a track record of improving quality metrics in a global biopharma setting. Hybrid work in the United States is offered.

Qualifications

• B.S. or B.A. degree in Life Science or health-related field and 10 years of relevant QA/biopharma experience
• Quality professional with 5+ years hands-on QA/Quality Engineering experience
• Extensive GMP experience with commercial products, global exposure
• Deep knowledge of US GxP and EU GMP requirements
• Experience with Product Complaints management and regulatory interactions

Responsibilities

• Maintain GxP quality systems, processes and procedures for compliance and continuous improvement
• Track and trend quality records (deviations, investigations, CAPA) with cross-functional teams
• Provide QA oversight for risk assessments and regulatory compliance activities
• Support regulatory inspections, submissions and external audits
• Own Product Recall processes and escalation of quality defects to authorities
• Author, review and approve GMP controlled documents

Skills

Quality metrics

Veeva QMS

Regulatory knowledge

Quality engineering

English proficiency

Education

Life science degree

Tools

GxP software

Job description

Sarepta Therapeutics is seeking a Sr. Manager, QA Compliance to lead quality systems across manufacturing, QC and MS&T. You will collaborate cross-functionally to trend data, manage recalls, and support regulatory activities for Sarepta’s commercial products.

The role requires strong GMP experience, independent judgment, and a track record of improving quality metrics in a global biopharma setting. Hybrid work in the United States is offered.