Executive Director, GCP Quality & Inspection Readiness

Aura Biosciences; Boston (MA); On-site; USD 240,000 - 305,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Employee Stock Purchase Program (ESPP)

Unlimited PTO

Disability & life insurance

Job summary

Aura Biosciences seeks an Executive Director, GCP Quality Assurance to lead global clinical quality across the portfolio. This role shapes risk-based strategies, ensures inspection readiness, and partners with Clinical Development, Regulatory Affairs, and Medical Affairs to uphold compliance and patient safety.

Responsibilities include directing GCP QA systems, CRO oversight, and regulatory inspections (FDA BIMO), building a proactive quality culture and providing strategic guidance to senior

Qualifications

• Minimum 15+ years in GCP Quality Assurance within pharma/biotech.
• Proven leadership supporting global clinical development.
• Strong knowledge of GCP, ICH, FDA requirements.
• Experience with CRO/vendor oversight, audits, CAPA, and inspection readiness.
• Demonstrated ability to influence senior leaders and drive risk-based decisions.

Responsibilities

• Lead the GCP Quality strategy for late-stage clinical programs.
• Oversee global CROs, sites, and vendors for quality and compliance.
• Manage audit programs, CAPA, corrective actions, and remediation.
• Direct preparation for FDA BIMO and global regulatory inspections.
• Collaborate with Clinical Ops, Regulatory, and Medical Affairs on quality matters.
• Provide governance input to senior leadership on quality risk and program strategy.

Skills

GCP Quality Assurance

Regulatory Inspection Readiness

Quality Leadership

Cross-functional Collaboration

Risk Management

Education

Bachelor's degree in life science

Tools

GCP QA Systems

ICH E6 Knowledge

Job description

Aura Biosciences seeks an Executive Director, GCP Quality Assurance to lead global clinical quality across the portfolio. This role shapes risk-based strategies, ensures inspection readiness, and partners with Clinical Development, Regulatory Affairs, and Medical Affairs to uphold compliance and patient safety.

Responsibilities include directing GCP QA systems, CRO oversight, and regulatory inspections (FDA BIMO), building a proactive quality culture and providing strategic guidance to senior