Senior QA Auditor

About the role

IQVIA, a global provider of clinical research services, commercial insights and healthcare intelligence, is hiring a Senior QA Auditor in Durham. The role centres on planning and running independent audits to check compliance with regulations, guidelines and operating procedures, reporting findings and advising teams and customers on compliance.

Key responsibilities

• Plan, schedule, conduct, report and close audits across the countries involved in IQVIA contracts, covering regulations, guidelines, customer requirements, IQVIA SOPs and project-specific instructions
• Evaluate audit findings and prepare reports for operations staff, management and customers
• Advise project teams, customers and monitors on regulations, compliance status and corrective action plans
• Manage quality issues: review and approve investigations, root cause analyses, CAPA and effectiveness checks, and track them to closure
• Deliver quality assurance consultancy and projects for clients within budget and timelines
• Review policies and procedures for compliance and recommend improvements
• Host audits and inspections, including customer-initiated audits and mock regulatory inspections
• Maintain quality event updates in the electronic quality management system (eQMS) and support the audit lifecycle
• Support QA initiatives, train new QA staff and may perform GLP archivist duties

Required profile

• Bachelor's degree preferred; equivalent combination of education, training and experience accepted
• 5 years of experience in pharmaceutical, technical or related areas, including 3 years in Quality Assurance, with GxP experience
• Extensive knowledge of pharmaceutical R&D processes and regulatory environments
• Strong interpersonal, problem-solving, risk analysis and negotiation skills, and ability to work independently and manage multiple projects

Required skills

• Knowledge of quality assurance processes and procedures
• Word processing, spreadsheet and database applications
• Ability to interpret regulations and guidelines and to consult on compliance

The potential base pay range is $75,400 to $188,600 per year, depending on qualifications, location and schedule; incentives, bonuses and benefits may also apply.