Associate Director, Clinical Study Quality Lead; Hybrid

Job Description General

Summary:

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.

• 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…