Associate Director, Tech Quality Assurance

Associate Director, Tech Quality Assurance Associate Director, Tech QA will work with IQVIA divisions including its wholly owned subsidiary and laboratory division, IQVIA Laboratories. IQVIA and IQVIA Laboratories is a leading global clinical trial services and product organization providing laboratory services with comprehensive testing, project management, supply chain, biorepository and specimen management, and clinical trial sample and consent tracking solutions.Job Profile Summary The role involves leading technology quality assurance activities globally within IQVIA, ensuring compliance with GXP regulations, GAMP guidelines, customer requirements, and IQVIA SOPs. The position requires a combination of audit oversight, regulatory expertise, and management of quality events in an eQMS.Essential FunctionsOrganize, plan, schedule, conduct, report, and close Clinical Trial Laboratory Technology Systems Audit activities worldwide to assess compliance with applicable GXP regulations/GAMP guidelines and IQVIA SOPs.Lead and manage a team of technology auditors and specialists.Evaluate audit findings, prepare reports, and ensure corrective/preventive actions are followed up.Maintain and update the electronic quality management system (eQMS) throughout the audit lifecycle.Review, approve investigations, root cause analysis (RCA), corrective action prevention (CAPA), and effectiveness check (EC) plans; track closures for quality events.Stay current with regulatory developments (GxP, 21 CFR Part‑11, EU Annex 11, GAMP, ICH, risk management)芯 ensure compliance.Collaborate with IT, QA, and business functions on validation of new systems and improvement of existing IT quality processes.Interpret and implement regulatory controls for project teams on regulations, guidelines, compliance status, and policies वालधार.Evaluate policies and procedures for compliance; provide recommendations for continuous improvement.Lead or support QA initiatives/projects for quality and process improvements.Manage training of new QA staff and guide operational staff on compliance procedures.Represent the Technology QA Team at audits and client meetings when necessary.Requirements7–10 years of experience in CRO, Pharmaceutical, or Biotechnology.7–10 years of Quality Assurance experience.3–5 years of direct line management experience.Experience with regulated equipment maintenance programs and laboratory instrumentation workflows such as QLIMS, ULTRA, Chromeleon, Spectrophotometer, Top CAT, and ABI Sequencers.Strong GXP experience and thorough understanding of clinical trials.Experience with third‑party audits and internal audits of Clinical Trial sub‑systems.Experience 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 testing methodologies, documentation, and product specifications in an FDA‑regulated environment.Knowledge of 21 CFR Part 11, Electronic Records – Electronic Signatures, Good Automated Manufacturing Practices (GAMP), and other relevant regulatory guidelines.Comfortable with GxP computerized systems documentation (validation plans, specifications, risk assessments, test plans, qualification protocolsVMველი).Location & TravelRemote Opportunity.5–10% travel may be required in the EMEA region.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. Learn more at https://jobs.iqvia.com.#J-18808-Ljbffr