Executive Director, Clinical QA

Role Summary

Executive Director, Clinical QA — Provides vision, strategic planning and management for departmental initiatives. Responsible for developing and setting strategy and operating plans for Clinical QA, and establishing compliance, procedures, and quality leadership. Leads a team of quality professionals to implement quality systems and ensure QA support of clinical study teams. Leads pre-approval inspections and clinical audits and coordinates cross-functional activities to meet quality standards and risk-based principles. Mentors and coaches QA staff and manages department performance.

Responsibilities

• Drives the strategic vision and direction for Clinical QA group
• Develops, evaluates and adjusts strategy for Clinical QA and builds relationships with stakeholders to achieve GCP compliance and quality objectives
• Leads development, implementation and communication of the GCP QA vision, goals, capabilities, and values; champions a strong Quality Culture
• Advises with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs on compliance issues and provides quality guidance
• Oversees regulatory inspections preparations, including inspection readiness planning, mock inspections, pre-approval inspections, and risk-based management of quality events
• Leads and project manages development and enhancements to the clinical QMS
• Evaluates and oversees global clinical investigators, contract laboratories, and CROs
• Monitors regulatory status of principal investigators and coordinates remediation and corrective actions
• Supports IND/CTA submissions and related regulatory correspondence
• Develops metrics for compliance activities and communicates them to upper management
• Performs investigator site and vendor audits to ensure GCP/regulatory compliance
• Directs compliance activities related to drug safety and pharmacovigilance, phase IV studies, and investigator-initiated trials
• Oversees internal audits to ensure policies and procedures are compliant with GCP principles
• Other duties as assigned

Qualifications

• RN, BSN, BS/MS, or BA degree or equivalent with 17+ years of industry experience including GCP leadership roles; extensive GCP audits/inspections; experience developing GCP QA systems; previous managerial experience
• Or Master‚Äôs Degree with 15+ years of relevant experience
• In-depth knowledge of Clinical Trial regulations (FDA, ICH) and international GCP guidelines
• Ability to design and conduct audits of investigator sites and vendors for Phase I‚ÄìIV studies; strong auditing principles and communication skills
• Ability to collaborate with internal and external stakeholders to improve compliance and operations
• Strong understanding of FDA and EMA regulations and GxP knowledge; experience with quality systems and regulatory compliance for clinical QA
• Demonstrated leadership, strategic thinking, and project management skills; excellent communication and relationship-building abilities
• Ability to mentor, influence change, and develop QA teams; comfortable with complex, cross-functional initiatives
• Self-motivated, hands-on problem solver with collaborative leadership style
• Commitment to high ethical standards and accountability

Skills

• GCP, GLP, and GMP expertise across product lifecycle
• Quality systems design and implementation
• Regulatory inspection readiness and management
• Vendor and CRO oversight
• Strong analytical, leadership, and communication skills

Education

• RN, BSN, BS/MS, or BA/BS with relevant health/clinical science field; advanced degree preferred

Additional Requirements

• International travel as needed for regulatory activities and inspections