GCP Operational Quality Senior Manager

Job Description General Summary

The Senior GCP Operational Quality Manager conducts quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring quality issues and compliance metrics, investigation and CAPA management, and proactive inspection readiness activities.

• Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation, consultation, and other support services necessary to maintain and/or improve the quality of Vertex research to ensure the protection of subjects’ safety, rights, and well-being as well as the integrity and credibility of data generated.
• Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP).
• Liaise with Vertex clinical functions and external parties including CROs, Vendors and investigator sites to promote high level of quality and consistency across and within programs.
• 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.
• Manages and/or leads domestic and international audits for Clinical Investigators, to ensure compliance to ICH GCP, applicable regulations, and company standards.
• For assigned programs/ studies, leads quality issue investigations, root cause analysis and CAPA development and assist study teams in implementing corrective and preventive actions in support of sustainable compliance.
• Contributes to the development and implementation of continuous quality improvement initiatives.
• Engages with study teams and functions for proactive inspection readiness across assigned programs.
• Provides inspection support as necessary for Regulatory Agency inspections held at Vertex facilities or Clinical Investigator sites.
• May serve as GCP Quality Management System representative
• Participates in collaborative review of impacted SOP/WI
• Reviews and analyzes key Performance Indicator data and trends
• Analyzes risk and proposes remedial, corrective and /or preventive actions
• May participate on process improvement initiatives
• Develop and maintain QA to QA relationships with GCP Vendors to conform to quality agreements, and participates in applicable Vendor Joint Operating Committees, as needed.

• In-depth knowledge of ICH GCP R2 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments, etc.)
• Strong experience with all phases of clinical trial development involving drugs, biologics, devices and drug/ device combinations.
• In-depth knowledge of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.
• Ability to understand and translate customer needs, bringing a new perspective to existing quality management solutions
• Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
• Ability to work independently with minimal guidance, organizing and…