Senior Manager, GCP & Clinical Quality

Socket.dev; Bedford (MA); Hybrid; USD 136,000 - 170,000; Full time

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics is seeking a Sr. Manager, Corporate Quality – GCP to provide program-level QA oversight across Clinical Development and Real-World Evidence.

You will ensure GCP compliance and guide trial teams through audits, CAPAs, and vendor assessments. Join a team focused on delivering high-quality clinical programs with global scope, including vendor management, inspections, and continuous quality improvements.

Qualifications

• BS/BA degree in a scientific discipline; advanced degree preferred.
• 8+ years experience in a related industry.
• 6+ years in Clinical Quality Assurance with audits.
• Experience with Global Clinical trial conduct and ICH/FDA/EU guidelines.
• Travel up to 10% domestically and internationally.

Responsibilities

• Provide program-level quality oversight for Clinical Development and Real-World Evidence.
• Act as SME in GCP compliance for trials and submissions.
• Lead integration of acquired programs into quality frameworks.
• Coordinate internal and external audits and CAPA activities.
• Support inspection readiness and continuous quality improvements.

Skills

GCP QA knowledge

Audit management

Cross-functional collaboration

Regulatory compliance

Travel readiness

Education

BS/BA in Science

Advanced degree preferred

Tools

CAPA systems

Quality Management Systems

Job description

Sarepta Therapeutics is seeking a Sr. Manager, Corporate Quality – GCP to provide program-level QA oversight across Clinical Development and Real-World Evidence.

You will ensure GCP compliance and guide trial teams through audits, CAPAs, and vendor assessments. Join a team focused on delivering high-quality clinical programs with global scope, including vendor management, inspections, and continuous quality improvements.