Associate Director, Quality Assurance (GCP & Clinical Research)

Location: Durham, North Carolina, United States of America

Salary: $88,600–$246,600 annual base pay

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Lead strategic Quality Assurance oversight across clinical research, clinical operations, pharmaceutical development, and GxP-regulated programs.
• Serve as the primary QA liaison for customers, sponsors, clinical operations groups, and internal functional teams.
• Guide quality issue management, deviations, CAPAs, risk assessments, compliance initiatives, and quality management systems.
• Support regulatory inspections, sponsor and customer audits, inspection readiness, and corrective and preventive action verification.
• Develop and maintain QA policies, procedures, SOPs, quality strategies, and metric reporting.
• Lead quality improvement initiatives, analyze audit and compliance trends, and mentor and manage QA personnel.

Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, healthcare administration, biology, chemistry, or a related scientific discipline, or equivalent education and experience.
• At least 10 years of Quality Assurance experience in pharmaceutical, biotechnology, CRO, medical device, healthcare, or clinical research environments.
• Extensive experience applying and overseeing Good Clinical Practice standards in clinical research.
• Strong knowledge of pharmaceutical research and development, clinical trial conduct, GxP Quality Assurance, and global regulatory environments.
• Experience leading complex quality initiatives, audits, investigations, CAPA activities, risk assessments, and stakeholder negotiations.
• Strong leadership, communication, organization, problem-solving, decision-making, and team-building skills, with proficiency in Microsoft Office and quality management systems.

Culture & Benefits

• Work across multiple functional areas, business units, customer engagements, and regional or global quality initiatives.
• Focus on patient safety, data integrity, regulatory compliance, accountability, and continuous improvement.
• Health and welfare benefits may be offered in addition to base pay.
• Incentive plans, bonuses, or other compensation may be available depending on the position.