Sr. QA Auditor - GCP

Job Description – Senior GCP Auditor (Updated)

Location: Bengaluru (Hybrid) | Global travel up to 20–40%

Essential Functions

• Plan, schedule, conduct, report, and close audit activities across countries to assess compliance with GCP regulations, customer requirements, SOPs, and study guidelines.

Audit Planning & Strategy

• Perform risk assessments on GCP-relevant vendors; determine audit type (onsite/remote/paper), scope, and audit frequency.

Audit Execution

• Lead qualification, routine, and for-cause audits of:

  - Site Management Organizations (SMOs)

  - Ethics Committees/IRBs

  - Investigator Sites

  - CRO service providers

  - Data Management and Biostatistics service providers

  - Review of Clinical Study Reports (CSR) to ensure GCP compliance and data integrity.

• Evaluate eClinical systems such as EDC, CTMS, eCOA, eConsent, and IRT for GCP relevance.

• Evaluate compliance with ICH E6(R2/R3), applicable regulations, SOPs, and study protocols.

• Document audit findings, classify risks, and prepare high‑quality audit reports.

• Provide interpretation of GCP regulations, guidelines, compliance status, and internal policies.

• Consult with study teams and vendors on audit observations and CAPA expectations.

• Manage Quality Issues as required.

• Deliver GCP training and compliance guidance to cross-functional teams.

• Review and approve RCA, CAPA, and Effectiveness Checks; track timely closure.

• Provide GCP guidance during regulatory inspection preparation.

• Host customer audits and regulatory inspections.

• Maintain audit documentation and quality records in the eQMS; support the audit lifecycle.

• Lead/support QA process improvement initiatives and mentor new QA staff.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.

• 8–12+ years of GCP QA/auditing experience, including CRO, SMO, EC/IRB, and investigator site audits.

• Strong knowledge of ICH E6(R2/R3), global GCP regulations, and CSR review practices.

• Experience conducting global audits and leading vendor qualification activities.

• Strong communication, documentation, analytical, and risk‑based decision‑making skills.

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.