Associate Director, Tech Quality Assurance

Associate Director, Tech Quality Assurance will work with IQVIA divisions, including its wholly owned subsidiary and laboratory division, IQVIA Laboratories, to assess compliance with GXP regulations and customer requirements. The role involves auditing Clinical Trial Laboratory Technology Systems, evaluating audit findings, and ensuring corrective/preventive actions are implemented. The Associate Director will also manage quality events, provide support in the electronic quality management system, and collaborate with IT members, QA, and business functions on validation and improvement of existing IT Quality processes.

Requirements

• 7-10 years of experience in CRO, Pharmaceutical or Biotechnology
• 7-10 years of Quality Assurance experience
• 3-5 yrs of Direct Line Management experience
• Experience with regulated equipment maintenance programs and familiarity with lab instrumentation workflows such as QLIMS, ULTRA, Chromeleon, Spectrophotometer, Top CAT, and ABI Sequencers
• GXP experience and thorough understanding of clinical trials
• Experience with 3rd Party Audits and Conducting Internal Audits of various Clinical Trial Quality Sub Systems
• Expert knowledge of Computer Systems Validation (CSV) in a life science or regulated environment required
• Experience with software validation and testing methodologies, documentation and product specifications in an FDA regulated environment

Benefits

• Competitive salary
• Benefits package
• Opportunities for career growth and development