Associate Director, Clinical Study Quality Lead (Hybrid)

Location: Boston, MA, with a hybrid option of up to two remote days per week or an on-site option five days per week. Travel up to 10% to Vertex sites, vendors, and investigator sites is required.

Salary: $160,600–$240,800 base salary, plus potential annual bonus and equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and improved patient outcomes.

What you will do

• Provide strategic, risk-based GCP quality oversight for clinical trials across assigned disease areas and development phases.
• Develop and execute audit, quality risk management, and inspection preparedness plans.
• Identify, communicate, and mitigate compliance risks, including oversight of quality events, investigations, CAPA plans, and effectiveness checks.
• Partner with clinical and functional teams on regulatory compliance, study quality, inspection preparation, and response activities.
• Review quality metrics, audits, service providers, procedures, and process improvement opportunities.
• Serve as a GCP subject matter expert, mentor junior Clinical Study Quality Leads, and potentially assume people management responsibilities.

Requirements

• Bachelor’s degree in a scientific or allied health field, or equivalent background, plus 8+ years of relevant experience.
• In-depth knowledge of ICH-GCP guidelines and global clinical development regulations, including FDA, EMA, and MHRA requirements.
• Experience across clinical trial phases involving drugs and biologics.
• Strong knowledge of event management, root cause analysis, CAPA planning, effectiveness checks, quality risk management, and inspection readiness.
• Scientific knowledge sufficient to oversee clinical trial quality, understand medical terminology and standards of care, and support ethical participant treatment.
• Strong communication, organizational, problem-solving, conflict-resolution, metrics-analysis, and Microsoft Office skills.

Nice to have

• Experience with medical device manufacturing and transition to clinical studies or Cell and Gene Therapy.
• Professional clinical trial certification such as CCRP or RQAP-GCP.

Culture & Benefits

• Hybrid or on-site flexibility under the Flex @ Vertex program.
• Medical, dental, and vision benefits with paid time off and summer and winter company shutdowns.
• Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
• Continuous learning opportunities related to AI, technology, automation, and industry trends.