Clinical Study Quality Lead, Associate Director

Job Description

Clinical Study Quality Lead (SQL), Associate Director – 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. The SQL is accountable for the development and execution of audit/quality plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, real‑time study inspection readiness oversight, and collaboratively identifying and driving inspection preparedness strategies and activities.

Companion to overall quality and compliance of internal operations and applicable vendors, with potential line‑management responsibilities.

• Serve as a key technical resource for the GCP clinical execution function with responsibility of assuring quality risk management/mitigation and adequacy and compliance with GCP regulatory requirements and guidance to ensure the protection of subjects' safety, rights, and well‑being as well as the integrity and credibility of data generated
• Liaise with clinical functions and external parties including CROs, Vendors, and investigator sites to promote high level of quality and consistency across and within programs.
• Partner with QA and business leadership for coordination and alignment in ensuring overall quality and compliance of internal operations and applicable vendors.
• Participate on Integrated Risk Governance Team responsible for assessing GCP compliance risk areas (internal and external) and develop and implement risk mitigation measures;
  Lead Stage Gate Reviews for advancing trials through clinical phases for assigned programs.
• Provide guidance, interpretation and information on regulations, standards and quality systems to GCP functional areas responsible for clinical trial execution.
• Develop and measure quality metrics to drive consistent quality standards relating to GCP activities to drive proactive and predictive quality improvements.
• Develop and lead inspection readiness activities for assigned programs.
• To drive process improvement, provide specialized knowledge and consultative guidance on GXP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.
• Participate in the evaluation and selection of GCP service providers.
• May provide functional area leadership and management.
• Performance Management (goals, monitoring, reviews).
• Employee Learning and Development (Identification of training needs and support of aspirational goals via IDP).
• Talent Acquisition/ Recruiting/ Interviewing/ selection.
• Onboarding/ Transition/ Succession Planning.
• Oversight of day‑to‑day execution.
• May serve as GCP Quality Management System representative.
• Participate in collaborative review of impacted SOP/WI.
• Review and analyze key Performance Indicator data and trends.
• Analyze risk and propose remedial, corrective and/or preventive actions.
• May participate on process improvement initiatives.
• Develop and maintain relationships with GCP Vendors to conform to quality agreements, and participates on applicable Vendor Joint Operating Committees, as needed.
• Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborates with study team in development of risk mitigation strategies.
• Develops risk‑based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies; assess impact of audit finding and other identified compliance risks to subject safety, data integrity and business operations and escalates significant compliance risks.
• Manages and/or leads domestic and international audits for Clinical Investigators, to ensure compliance to ICH GCP, applicable regulations, and company standards.
• S…