Associate Director, Tech Quality Assurance in Livingston

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.

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 (Good Automated Manufacturing Practices) guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.
• Thorough auditing evaluates the proper implementation of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), Laboratory Instrumentation and Equipment systems validation program, IT Quality Systems, and Technology in general.
• People management of Technology auditors and specialists.
• Evaluate audit findings and prepare and distribute reports to operations staff and management and ensure associated corrective/preventive actions (CAPA) are followed-up on and implemented.
• Manage/oversee quality events updates in the electronic quality management system (eQMS) and/or maintain the eQMS and provide support in relation to the audit lifecycle.
• Support review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during 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, etc. 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/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/support in QA initiatives/projects for quality, 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 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, including managing organizational responses to client or 3rd 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 whose products must be able to be validated to be compliant with 21CFR Part 11.
• 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 such as pharmaceutical, biotech or medical device required.
• 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.
• Comprehends 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.