Job Profile Summary
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 that provides laboratory services with comprehensive testing, project management, supply chain, biorepository, and specimen management, as well as clinical trial sample and consent tracking solutions.
Essential Functions
* Organize, plan, schedule, conduct, report, and close 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.
* People‑management of technology auditors and specialists.
* Evaluate audit findings and prepare and distribute reports to operations staff and management, ensuring associated corrective/preventive actions (CAPA) are followed up and implemented.
* Manage and oversee quality events updates in the electronic quality management system (eQMS), maintaining the eQMS and providing support throughout the audit lifecycle.
* Support review, approval, and tracking of investigations, root cause analysis (RCA), corrective action prevention (CAPA), and effectiveness check (EC) plans until closure for quality events arising from audits, inspections, or similar QA activities.
* Keep current with regulatory developments, including GxP, 21 CFR Part 11, EU Annex 11, GAMP, ICH, risk management, corporate policies, and procedures to ensure IQVIA meets or exceeds industry best practices for compliance and validation.
* Collaborate with other IT members, QA, and business functions on validation of new systems and improvement of existing IT quality processes and practices.
* Provide consistent interpretation and implementation of regulatory controls to project teams on regulations, guidelines, compliance status, and policies and procedures.
* Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
* Lead, collaborate, or support QA initiatives and projects for quality and process improvements.
* Manage the training of new Quality Assurance staff and provide guidance to operational staff on compliance procedures.
* Represent the Technology QA Team at audits and client meetings when necessary.
Requirements
* 7–10 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 familiarity with laboratory instrumentation workflows such as QLIMS, ULTRA, Chromeleon, Spectrophotometer, Top CAT, and ABI Sequencers.
* GxP experience and thorough understanding of clinical trials.
* Experience with third‑party audits and conducting internal audits of various clinical trial quality subsystems, including managing organizational responses to client or third‑party audit reports.
* Experience working in auditing and compliance of computer systems within an FDA‑regulated environment, such as clinical trials, or within a SaaS provider whose products target FDA‑regulated companies and must be validated to be compliant with 21 CFR Part 11.
* 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 such as pharmaceutical, biotech, or medical device.
* Knowledge of regulations and regulatory guidelines: 21 CFR Part 11, electronic records – electronic signatures, General Principles of Software Validation – Final Guidance for Industry and FDA Staff, GAMP guidelines, or other methodologies for computer systems validation in a regulated environment, and data integrity requirements.
* Comprehension of GxP computerized systems documentation such as validation plans, requirements and specifications, risk and gap assessments, test plans, qualification protocols, phase reports, and summary reports.
Location & Travel
* Remote 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. 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.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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