Senior Quality Manager
1 month ago
General Summary:
The Senior Quality Manager is responsible for conducting 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.
Key Duties and Responsibilities:
Serves as the Clinical Study 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.
Provides guidance, interpretation, and information on regulations, standards, and quality systems to GCP functional areas responsible for clinical trial execution.
Provides subject matter expertise and participates in the development and review of study-level documents (e.g., protocols, informed consent documents) and procedural documents related to the QMS (e.g., CAPA and Quality Issue Management, regulatory inspections, quality risk management).
Maintains a contemporary knowledge of current industry trends, standards, and methodologies as it relates to Good Clinical Practice (GCP).
Liaises with Vertex clinical functions and external parties, including CROs, vendors, and investigator sites, to promote a 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 teams in the 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 assists 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.
Develops and maintains QA to QA relationships with GCP vendors to conform to quality agreements and participates in applicable Vendor Joint Operating Committees, as needed.
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