Sarepta Therapeutics · 1 day ago
Associate Director, GCP, RCDQA
Bedford, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$161K/yr - $201K/yr
10+ years expSarepta Therapeutics is a leader in genetic medicine, focusing on Duchenne muscular dystrophy and other diseases. The Associate Director, GCP, RCDQA will oversee quality assurance for clinical development, ensuring compliance with regulations and guidelines while supporting clinical trial teams throughout the trial lifecycle.
BiotechnologyGeneticsHealth CareTherapeutics
No H1B
Responsibilities
Provide proactive GxP QA support and guidance to Clinical Trial Teams, leveraging analysis and interpretation of GxP regulations to ensure best practices in Clinical and QA operations
Lead integration of acquired clinical programs into existing quality frameworks, ensuring seamless transition of processes, systems, and compliance standards following mergers, acquisitions or partnerships
Partner with teams to resolve compliance issues identified at clinical vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions
Assist in the development and implementation of CAPA plans and investigations in response to quality issues, audits, and inspections
Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements
Develop and maintain study-specific audit plans for assigned studies; support audit preparation, site selection, and execution, including coordination of responses
Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies
Support inspection readiness activities for sponsors, monitors, and sites; provide guidance and hands-on support during all GxP inspection activities
Coordinate and manage external audit consultants, as needed to ensure quality and consistency
Perform other related duties and special projects, as assigned
Qualification
Required
BS/BA Degree in a scientific discipline
10+ years experience in a related industry
8+ years experience in a Clinical Quality Assurance role, including experience with external and internal audits
Demonstrated experience working with clinical trial teams
Broad experience in conducting global clinical trials, along with a comprehensive understanding of relevant ICH Guidelines, FDA regulations, and EU requirements
Skilled in developing and managing Quality Management Systems
Strong interpersonal skills, integrity, professionalism, and ability to build effective relationships with staff across all levels
This position may require up to 10% domestic & international travel
Preferred
Advanced degree preferred
Previous experience in supporting regulatory authority inspections preferred
Benefits
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
Competitive compensation and benefit package
Company
Sarepta Therapeutics
Sarepta Therapeutics focuses on the discovery and development of precision genetic medicine to treat rare diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.88BKey Investors
Michael Andrew ChambersPharmakon AdvisorsMidCap Financial
2025-12-11Post Ipo Debt· $291.4M
2025-08-21Post Ipo Equity
2025-08-21Post Ipo Debt· $602M
Leadership Team
Ian Estepan
Executive Vice President, Chief Financial Officer
K
Kathy Behrens Wilsey
Director
Recent News
2026-01-24
Genetic Engineering News
2026-01-23
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