Associate Director, Quality Assurance (Clinical Research Preferred)

- 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.

- 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. - 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 https://jobs.iqvia.com

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.