Associate Director, Clinical Study Quality Lead (Biotech)

Location: Boston, MA, United States. Hybrid work allows remote work up to two days per week, or on-site work five days per week with ad hoc flexibility. Travel up to 10% to company sites, vendors, and investigator sites is required.

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

Company

Vertex is a global biotechnology company focused on scientific innovation and developing therapies for patients.

What you will do

• Provide strategic, risk-based GCP quality oversight for clinical studies across assigned disease areas and development phases.
• Develop and execute quality, audit, and inspection-readiness plans in partnership with clinical and functional teams.
• Identify, assess, communicate, and mitigate compliance risks through risk management forums and quality plans.
• Oversee quality event investigations, root cause analysis, CAPA plans, effectiveness checks, and audit responses.
• Represent Quality in study governance, management reviews, process improvement initiatives, and cross-functional forums.
• Mentor junior Clinical Study Quality Leads and may progress to people management responsibilities.

Requirements

• Bachelor’s degree in a scientific or allied health field, or equivalent, with 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 development phases involving drugs and biologics.
• Strong knowledge of event management, investigations, root cause analysis, CAPA development, and effectiveness checks.
• Strong organizational, problem-solving, conflict-resolution, communication, and collaboration skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, Smartsheet, and Visio, plus quality metrics analysis and trending.

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 work options under the Flex @ Vertex program.
• Medical, dental, and vision benefits, paid time off, and seasonal company shutdowns.
• Educational assistance programs, including student loan repayment support.
• Commuting subsidy, matching charitable donations, 401(k), and other total rewards.
• Continuous learning focused on advances in AI, technology, automation, and industry trends.