Associate Director, Tech Quality Assurance

Associate Director, Tech Quality Assurance will work with IQVIA divisions to assess compliance with applicable GXP regulations/GAMP guidelines, customer requirements, IQVIA SOPs, and project specific guidelines/instructions. The role involves auditing Clinical Trial Laboratory Technology Systems, managing technology auditors and specialists, and ensuring associated corrective/preventive actions are followed-up on and implemented.

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
• Experience with software validation and testing methodologies, documentation and product specifications in an FDA regulated environment
• Knowledgeable in the following regulations/regulatory guidelines: 21 CFR Part 11, Electronic Records – Electronic Signatures; General Principles of Software Validation - Final Guidance for Industry and FDA Staff; Good Automated Manufacturing Practices (GAMP) guidelines; or other methodologies for Computer Systems Validation in a regulated environment and Data Integrity requirements