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IQVIA

Runs drug trials and sells health data to pharma

Quality Assurance Auditor 2

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeAustin, TX, USAIn-person

About the Job

Requirements

  • A bachelor's degree or an equivalent combination of education, training, and relevant experience is required; an equivalent combination of education, training, and experience may be accepted in lieu of a degree.
  • At least 3 years of experience in Quality Assurance or a related role within a GxP-regulated pharmaceutical, laboratory, clinical research, or similar environment is required.
  • Working knowledge of GxP requirements and quality systems, with the ability to interpret and apply requirements in a regulated environment, is required.
  • Practical experience with CAPA, investigations, or quality events, including root cause analysis and corrective actions, is required.
  • Experience conducting or supporting quality audits, including audit preparation, execution, reporting, and follow-up activities, is required.
  • Strong written and verbal communication skills to communicate effectively across multiple functions and organizational levels.
  • Strong analytical and problem-solving skills, sound judgment, and the ability to make informed decisions.
  • Ability to work independently, manage competing priorities, build collaborative relationships, and drive activities through completion.

Responsibilities

  • Independently plan, conduct, document, and close internal audits to assess compliance with applicable regulations, client requirements, SOPs, and quality standards.
  • Review audit observations, communicate findings, and track corrective actions through completion.
  • Support CAPA activities from initiation through investigation, action planning, effectiveness checks, and closure.
  • Monitor audit and CAPA metrics, analyze trends, and contribute to quality performance reporting.
  • Host customer audits and support regulatory inspections, including preparation, responses, and follow-up activities.
  • Provide Quality Assurance guidance on compliance requirements, quality systems, policies, and procedures across Protein Biomarkers departments.
  • Maintain accurate documentation within the electronic Quality Management System and support training and continuous improvement initiatives.

Desired Qualifications

  • Experience working within an electronic Quality Management System (eQMS).
  • Experience independently planning, conducting, reporting, and following up internal audits.
  • Experience reviewing investigations, root cause analyses, CAPA plans, and effectiveness checks.
  • Experience supporting or hosting customer audits and regulatory inspections.

About the Company

IQVIA

Runs drug trials and sells health data to pharma

IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.

Company size
10,001+
Company stage
IPO
Headquarters
Durham, NC
Founded
1998

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