Director, Global Quality & GxP Compliance

Socket.dev; Bedford (MA); On-site; USD 186,000 - 232,000; Full time

Job summary

Sarepta Therapeutics is seeking a Director, Corporate Quality to provide leadership and strategic quality oversight across Clinical Development and Real-World Evidence portfolios. You will be the SME for GCP and GLP compliance, ensuring trials and studies meet FDA regulations and ICH guidelines.

In this hybrid role, you will partner with Clinical Development, Operations, Pharmacovigilance and Research to drive end-to-end regulatory compliance, scientific integrity, and patient safety across

Qualifications

• BS/BA in a scientific discipline; advanced degree preferred.
• 12+ years of progressive experience in a related industry.
• 8+ years in Clinical Quality Assurance with audits.
• Experience with global clinical trials and regulatory guidelines.
• Experience supporting regulatory authority inspections preferred.

Responsibilities

• Provide leadership on GCP/GLP QA support to key stakeholders across Clinical/Non-Clinical/QA operations.
• Act as primary QA partner to R&D leaders across Clinical, Non-Clinical, Research & Pharmacovigilance.
• Partner with teams to resolve compliance issues at vendors/sites; assess deficiencies and recommend actions.
• Develop and implement CAPA plans and investigations in response to quality issues, audits, inspections.
• Review clinical trial documentation and regulatory submission materials for completeness and compliance.
• Develop study-specific audit plans and coordinate responses; support inspections.

Skills

GCP/GLP QA leadership

Interpersonal skills

Regulatory compliance knowledge

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Sarepta Therapeutics is seeking a Director, Corporate Quality to provide leadership and strategic quality oversight across Clinical Development and Real-World Evidence portfolios. You will be the SME for GCP and GLP compliance, ensuring trials and studies meet FDA regulations and ICH guidelines.

In this hybrid role, you will partner with Clinical Development, Operations, Pharmacovigilance and Research to drive end-to-end regulatory compliance, scientific integrity, and patient safety across