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. The role involves organizing, planning, scheduling, conducting, reporting, and closing Clinical Trial Laboratory Technology Systems Audit activities in IQVIA globally or its affiliates to assess compliance with applicable GXP regulations/GAMP guidelines, customer requirements, IQVIA SOPs, and project-specific guidelines/instructions. The position also involves people management, evaluation of audit findings, and quality event management.

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
• Experience working in auditing and compliance of Computer Systems within an FDA regulated environment
• 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

• Retirement Plan
• 401k Matching