Sr Director, GCP Quality Assurance

The Sr. Director, GCP Quality Assurance oversees the development, implementation, and maintenance of quality assurance systems and activities that support clinical trial quality, GCP compliance, and program-level quality oversight.

Oversees the development, implementation, and maintenance of quality assurance systems and activities that support clinical trial quality, GCP compliance, and program-level quality oversight. Serves as a senior QA partner for assigned clinical development programs, providing independent, risk-based oversight without assuming responsibility for study operations. Directs the generation and review of documentation used in clinical quality systems, trial oversight, and other GCP-regulated activities, and leads internal and external audits involving investigator sites, vendors, and clinical processes.

Leads investigations and supports resolution of clinical quality and compliance issues, including protocol deviations, CAPAs, audit findings, and site- or vendor-related concerns, to strengthen quality and operational effectiveness. May select, develop, and evaluate staff to support effective function operations. This role contributes to and supports the company’s research and development efforts to advance therapeutic programs that address unmet medical needs.

Oversees the development, implementation, and maintenance of quality assurance systems and activities for clinical trial quality and GCP compliance.

Oversees the generation and review of documents used in clinical quality systems, trial oversight, and GCP-regulated activities. Also oversees internal and external audits for GCP activities, including investigator sites, vendors, and clinical processes.

Leads investigations and supports resolution of clinical quality and compliance issues, including protocol deviations, CAPAs, inspection findings, and vendor- or site-related quality concerns.

Provides clinical quality expertise and strategic leadership for Phase I-IV clinical development, including trial conduct, inspection readiness, and cross-functional quality support.

Provides independent, risk-based QA support for assigned clinical programs by reviewing and challenging protocol risk assessments and critical-to-quality assessments; reviewing Sponsor and Vendor Oversight Plans; assessing relevant quality metrics, trends, significant issues, and CAPAs; confirming that vendor oversight and escalation are appropriately documented; and supporting audit follow-up and inspection evidence readiness.

Provides guidance on regulatory standards, compliance strategies, ICH-GCP, clinical trial regulations, inspection readiness, and clinical quality documentation.

Represents Quality Assurance on clinical development teams, governance forums, and cross-functional trial teams, as needed, while maintaining appropriate separation from Study Operations responsibilities.

Leads the implementation of electronic reporting for deviations, CAPAs, audit findings, inspection readiness tracking, and clinical quality metrics.

Contributes significantly to health authority inspection readiness, sponsor oversight, and clinical trial quality readiness efforts.

Experience with clinical quality documentation systems, document review, and GCP auditing responsibilities is required.

Comprehensive knowledge of ICH-GCP, applicable global clinical regulations, and clinical quality standards, and the ability to interpret and apply regulatory requirements effectively, is required.

Working knowledge of clinical quality systems, quality risk management, data analysis, statistics, and computer-based systems is required.

Experience providing program-level QA support, including review of protocol risk or critical-to-quality assessments, sponsor or vendor oversight plans, significant quality issues or CAPAs, and inspection-readiness evidence, is preferred.

Experience supporting clinical audits, investigator site oversight, vendor quality oversight, or inspection readiness activities is preferred. Strong verbal and written communication skills are required.

Demonstrates sound judgment, a commitment to…