Associate Director, Quality Assurance (Clinical Research Preferred)

Job Overview

Provide strategic quality leadership and oversight across assigned Quality Assurance (QA) programs with a strong focus on clinical research clinical operations pharmaceutical development and GxP-regulated activities. Influence quality outcomes across multiple 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 a regional and/or global level. Partner with stakeholders to assess and promote compliance with applicable regulatory requirements industry guidelines and company procedures while driving continuous improvement risk mitigation patient safety and operational excellence.

This position is best suited for candidates with substantial Clinical Quality Assurance (CQA) GCP GxP pharmaceutical biotechnology CRO healthcare or clinical research experience. While experience supporting technology-enabled quality systems is valuable candidates with a predominantly IT Quality Assurance background and limited exposure to regulated clinical environments may not possess the preferred qualifications for this role.

Essential Functions

• Serve as the primary QA liaison for assigned customers sponsors clinical operations groups and internal functional areas.
• Provide Quality Assurance oversight and guidance of 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 guidance interpretation training and consultation regarding regulations industry standards corporate policies and quality expectations to clinical and operational teams.
• Support inspection readiness activities and support responses to regulatory authority inspections sponsor audits and customer audits.
• Assist in the enhancement of Quality Assurance policies procedures and risk management programs by providing recommendations to regional and global QA leadership.
• Author review and maintain Quality Assurance Standard Operating Procedures (SOPs) and serve as a representative on global quality governance initiatives if assigned.
• Support customer audits and regulatory inspections and support the development implementation and verification of corrective and preventive action (CAPA) plans.
• Support documentation investigation reporting and resolution of compliance-related issues.
• Support Quality Management with proposal reviews quality strategy development and quality metric reporting.
• Analyze audit trends compliance metrics root causes and quality indicators to identify opportunities 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 a culture of quality compliance accountability and continuous improvement.

Promote patient safety data integrity regulatory compliance and quality excellence throughout the organization.

Qualifications

• Bachelors 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.
• Demonstrated experience in GxP Quality Assurance
• Strong knowledge of pharmaceutical research and development processes clinical trial conduct and global regulatory environments.
• 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.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.