Associate Director, Quality Assurance (GCP & Clinical Research)

IQVIA; Indianapolis (IN); On-site; USD 89,000 - 247,000; Full time

Job summary

IQVIA is seeking a strategic Quality Assurance leader to oversee QA programs across clinical research, GxP-regulated activities, and regulatory compliance. The role focuses on risk-based decision making, patient safety, and operating with global quality governance in mind.

The ideal candidate has extensive CQA experience, deep GCP/GxP knowledge, and a proven ability to manage audits, CAPA processes, and cross-functional initiatives across multiple regions.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology, Chemistry, or related field preferred
• Minimum of 10 years of Quality Assurance experience in pharma/biotech/CRO/medical device/clinical research environments
• Extensive experience interpreting and overseeing GCP standards in clinical research
• Experience leading audits, CAPA activities, and quality initiatives is advantageous
• Proven ability to influence stakeholders across functions and levels

Responsibilities

• Serve as primary QA liaison for assigned customers, sponsors, and clinical operations groups
• Provide QA oversight of deviations, CAPAs, risk assessments, and compliance initiatives
• Act as SME in GCP, GxP, ICH guidelines and pharmaceutical quality requirements
• Guide regulations and quality expectations to clinical and operational teams
• Support inspection readiness and regulatory inspections and sponsor/customer audits
• Contribute to QA policy, SOPs, risk management and global governance initiatives
• Develop and maintain CAPA plans and assist in investigations and reporting
• Analyze audit trends and quality indicators to drive process improvements

Skills

GxP Compliance

Audits & CAPA

Quality Assurance Leadership

GCP Knowledge

Regulatory Guidance

Education

Bachelor’s degree in Life Sciences/related field

Job description

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

• 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.

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 https://jobs.iqvia.com

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. https://jobs.iqvia.com/eoe

IQVIA 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.

The potential base pay range for this role, when annualized, is $88,600.00 - $246,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.