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 will ensure 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.  Overall, the SQL is responsible 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. 

This position may evolve to include line management responsibilities.

Key Duties and Responsibilities:

• Serves as key technical resource and GCP subject matter expert, to clinical study execution functions. 

• Provides strategic, risk-based GCP quality compliance oversight of studies within assigned disease areas to drive compliance with regulatory requirements to ensure the protection of participants’ safety, rights, and well-being as well as the integrity and credibility of study data generated.

• Provides 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 supports and/or identifies study/program quality risks ensuring that risks are communicated and mitigated in a timely manner.

• Participates in risk management forums with responsibility for assessing 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 strategy 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)

• May provide 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, etc. as well as on interdepartmental process improvement and business initiatives involving GCP systems, processes, procedures, regulations, and tools.

• May provide subject matter expertise and participate 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, current industry trends, standards, and methodologies and regulatory environment as relates 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 for and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions).

• May act on behalf of overseeing Clinical Quality Program Lead

• Mentor and train junior SQLs, as needed

• Role may progress to include people management responsibilities including hiring, oversight of day-to-day execution, employee goal setting, performance management, and career development activities

Education and Experience:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 8+ years of relevant work experience, or relevant comparable background

Required Experience:

• 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

• Communicates professionally, clearly, and concisely both verbally and in writing to internal and external customers

• Excellent organizational skills, problem solving and conflict resolution skills

• Must be able to organize and prioritize work effectively to meet timelines with quality deliverables

• Must possess the necessary scientific education and knowledge to manage quality oversight for clinical trials, understand medical terminology, standards of care and disease states to assure the ethical treatment of participants

• Must be able 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.

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