Director, Clinical Quality Assurance
$198,000–$225,000 year
On-site · Boston, Massachusetts, United States
Job Summary
Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs, develops risk-based QA strategies, manages audits and inspections, and oversees vendor quality systems to ensure global regulatory compliance. The role partners across functions to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. Responsibilities include audit planning, coordinating site/vendor audits, managing deviations and CAPAs, providing regulatory guidance, supporting IND activities, developing GMP/GCP training, and ensuring service providers adhere to quality programs.
Required Qualifications
- Bachelor’s degree in life sciences or related field
- 12+ years of related experience, 8+ years in Clinical Quality Assurance or PV/QA
- Deep knowledge of FDA/EMA regulations and ICH, GVP, GxP guidelines
- Experience leading clinical site and supplier audits; regulatory inspections; CAPA and risk-based QA programs
- Strong communication skills (verbal and written) and cross-functional collaboration
- Willingness to travel up to 20%
Desired Qualifications
- Strong leadership and collaboration
- GCP/Regulatory compliance expertise
- Auditing and inspection readiness
- Vendor oversight and CAPA management
- IND experience and regulatory submissions
- Policy, SOP development and training
- Data integrity and subject safety focus
- Travel readiness up to 20%
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