Executive Director, Clinical Quality Assurance

Job overview

The Executive Director, Clinical Quality Assurance role is onsite in Brighton, MA. Compensation is $240,000–$305,000 per year. Aura Biosciences is developing bel-sar, a potential therapy for ocular cancers, with a mission to improve patient outcomes while preserving vision and quality of life. This executive leads GCP Quality strategy and oversight across the clinical development portfolio, building an inspection-ready, risk-based quality framework. The role advises cross-functional and senior leaders, oversees clinical partners and quality systems, and leads regulatory inspection readiness to support compliant clinical development.

What you'll do

• Develop and lead GCP Quality strategy and the Clinical Quality Management System
• advise clinical and regulatory functions on quality and compliance
• oversee CROs, investigators, vendors, audits, quality events, CAPA, and remediation
• lead GCP inspection readiness and FDA BIMO and other regulatory inspections
• report quality risks and metrics to governance and senior leadership
• guide GCP training and continuous improvement
• coach GCP Quality personnel.

What we're looking for

Skills & competencies

executive director

clinical quality assurance

gcp quality

clinical development

inspection readiness

fda bimo

cro oversight

brighton ma

aura biosciences

$240k–$305k/year

full-time

Work arrangement

• Weekend coverage required

Benefits & perks

• Health insurance with full premium coverage
• 401(k) with company match
• Employee Stock Purchase Program
• unlimited paid time off
• company-paid short- and long-term disability and life insurance.

Why this role

Executive-level GCP Quality leadership for global clinical development, including pivotal and late-stage programs and FDA BIMO inspection readiness.

About the employer

Aura Biosciences is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.