Clinical Study Quality Lead, Associate Director

About the Role

The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight of clinical trial operations and applicable vendors across a range of study phases within assigned disease area(s). The SQL ensures clinical trials are conducted in accordance with GCP requirements, applicable protocols, Vertex policies and procedures, and quality standards as set forth in the Quality Management System. This role involves developing and executing audit/quality plans, identifying and communicating compliance risks, overseeing action plans to mitigate risks, and driving inspection preparedness strategies.

This position may evolve to include line management responsibilities.

Responsibilities

• Serves as a key technical resource and GCP subject matter expert for clinical study execution functions.
• Provides strategic, risk-based GCP quality compliance oversight of studies within assigned disease areas to ensure compliance with regulatory requirements, participant safety, rights, and well-being, as well as data integrity and credibility.
• Offers consultation, interpretation, and information on regulations, standards, and quality systems to clinical study execution functions.
• Partners with clinical and other study functional teams to engage proactive quality management approaches in support of risk mitigation and quality outcomes.
• Proactively identifies and supports study/program quality risks, ensuring timely communication and mitigation.
• Participates in risk management forums to assess GCP compliance risk areas; develops and implements quality risk management plans and measures.
• Partners with operational teams to develop risk-based quality and/or audit plans for assigned programs, ensuring audits are conducted in accordance with the plan. Reviews audit reports and may evaluate responses and CAPA plans.
• Develops and executes inspection preparedness strategies for assigned studies/programs in collaboration with Functional Area and Quality partners. Participates in inspection activities from preparation to response execution.
• Conducts directed or for-cause audits and site inspection preparation visits as needed.
• Oversees investigation and approves quality event investigations and CAPA(s).
• Provides regular updates on study and program status to the R&D Quality Leadership Team and senior stakeholders in GCP Quality. May provide direction and expertise at management review meetings on GCP-related activities/risks/issues.
• Represents Quality in study management and quality/compliance forums, teams, governance, and interdepartmental process improvement initiatives involving GCP systems, processes, procedures, regulations, and tools.
• Provides subject matter expertise and participates in the development and review of procedural documents related to the Quality Management System (e.g., CAPA, Quality Issue Management, regulatory inspections, quality risk management).
• Maintains an in-depth understanding of business principles, industry trends, standards, methodologies, and the regulatory environment related to clinical development, quality management, and Good Clinical Practice.
• Participates in the evaluation and selection of GCP service providers.
• Monitors key quality indicators and departmental metrics to identify opportunities for optimizing processes and procedures (SOPs, Work Instructions).
• May act on behalf of overseeing the Clinical Quality Program Lead.
• Mentors and trains junior SQLs, as needed.
• May progress to include people management responsibilities, including hiring, oversight of day-to-day execution, employee goal setting, performance management, and career development activities.

Requirements

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 8+ years of relevant work experience, or a relevant comparable background.
• In-depth knowledge and awareness of ICH-GCP guidelines and applicable global regulations and guidance for clinical development (e.g., FDA, EMA, MHRA, etc.).
• Experience across phases of clinical trial development involving drugs and biologics.
• In-depth understanding of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development, and Effectiveness Checks.
• Ability to understand and translate business partner needs for innovation and creative, risk-based approaches to quality management.
• Professional, clear, and concise communication skills, both verbally and in writing, for internal and external customers.
• Excellent organizational, problem-solving, and conflict resolution skills.
• Ability to organize and prioritize work effectively to meet timelines with quality deliverables.
• Scientific education and knowledge to manage quality oversight for clinical trials, understand medical terminology, standards of care, and disease states to ensure ethical treatment of participants.
• Ability to work independently and in a collaborative team setting.
• Proficient in using Microsoft Office applications (MS Word, MS Excel, MS PowerPoint, Smartsheet, Visio).
• Strong experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics.

Other Requirements

• Prior experience with medical device manufacture and transition to clinical studies or Cell and Gene Therapy is advantageous.
• Professional clinical trial certification (e.g., CCRP, RQAP-GCP, etc.) is preferred.
• Travel up to 10% is required to Vertex sites, vendors, investigator sites, etc.

Pay

The pay range for this role is $160,600 - $240,800. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on skills, competencies, experience, and other job-related factors permitted by law.

Benefits

• Inclusive market-leading medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) retirement plan and additional financial benefits.

Schedule

This is a Hybrid-Eligible role, allowing you to choose between:

• Hybrid: Work remotely up to two days per week.
• On-Site: Work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.