Associate Director, Quality Assurance – GCP, Clinical Research

• Provide strategic quality leadership and oversight across assigned Quality Assurance programs, focusing on clinical research, clinical operations, pharmaceutical development, and GxP-regulated activities
• Influence quality outcomes across functional areas, business units, and customer engagements through expert guidance, risk-based decision making, and oversight of quality systems and compliance programs
• Lead and coordinate QA initiatives supporting customer accounts, clinical and functional operations, audit and inspection readiness programs, and quality management systems at regional and/or global level
• Serve as the primary QA liaison for assigned customers, sponsors, clinical operations groups, and internal functional areas
• Provide QA oversight and guidance for quality issues, deviations, CAPAs, risk assessments, and compliance initiatives
• Serve as a subject matter expert in GCP, GxP, ICH guidelines, clinical trial regulations, and pharmaceutical quality requirements
• Provide regulatory, industry standards, policy, and quality expectation guidance, interpretation, training, and consultation
• Support inspection readiness and responses to regulatory authority inspections, sponsor audits, and customer audits
• Enhance QA policies, procedures, and risk management programs through recommendations to regional and global QA leadership
• Author, review, and maintain QA SOPs and represent global quality governance initiatives when assigned
• Support CAPA plan development, implementation, and verification
• Support documentation, investigation, reporting, and resolution of compliance-related issues
• Support proposal reviews, quality strategy development, and quality metric reporting
• Analyze audit trends, compliance metrics, root causes, and quality indicators for process improvement and risk reduction
• Lead or participate in cross-functional quality improvement initiatives and strategic projects
• Mentor, develop, and manage QA personnel while fostering quality, compliance, accountability, and continuous improvement
• Promote patient safety, data integrity, regulatory compliance, and quality excellence

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology, Chemistry, or related scientific discipline, or equivalent combination of education and experience preferred
• Minimum of 10 years of Quality Assurance experience within pharmaceutical, biotechnology, CRO, medical device, healthcare, or clinical research environments
• Extensive experience interpreting, applying, and overseeing compliance with Good Clinical Practice (GCP) standards within a clinical research environment
• Strong knowledge of pharmaceutical research and development processes, clinical trial conduct, and global regulatory environments
• Demonstrated experience in GxP Quality Assurance
• Experience conducting audits, authoring audit reports, evaluating findings, and managing CAPA activities is an advantage
• Proven ability to lead complex quality initiatives and influence stakeholders across multiple functions and organizational levels
• Excellent problem-solving, risk assessment, negotiation, and decision-making skills
• Strong organizational, communication, leadership, and team-building abilities
• Experience managing multiple projects, priorities, timelines, and competing business needs
• Ability to establish and maintain effective working relationships with customers, regulators, vendors, and internal stakeholders
• Proficiency with Microsoft Office applications and quality management systems

Demonstrates extensive expertise in Quality Assurance within pharmaceutical and clinical research environments, with a strong focus on GxP compliance, regulatory standards, and quality management systems. Proven ability to lead…