GCC Auditor

The GCC QA role is responsible for coordinating and maintaining Global GxP compliance programs and centralized QMS, including SOP governance, metrics, risk management, and inspection readiness. This role partners with cross-functional stakeholders to harmonize processes, respond to regulatory/client queries, and drive quality improvement initiatives across the organization.

Role & responsibilities

• Coordinate and maintain Global GxP compliance programs and centralized QMS.
• Develop, implement, and maintain Global QMS and SOPs for GxP systems.
• Compile and analyze quality metrics; drive quality improvement initiatives; report to site/global leaders.
• Review SOPs/QMS docs to ensure alignment with ICH-GCP and applicable regulations; harmonize processes.
• Lead/coordinate risk assessment and mitigation at the system and study level.
• Prepare responses to regulatory/client feasibility queries; facilitate client audits and regulatory inspections.
• Maintain a central repository for change controls, CAPA, deviations, inspections/observations; drive updates to QMS.
• Monitor regulatory/ethics updates; publish internal quality communications.
• Perform additional duties as assigned by the Supervisor / HOD/ Management.

Preferred candidate profile

• 8-10 years of experience in Quality Assurance within a CRO, Pharma, Clinical Research, BA/BE, or Life Sciences environment.
• Hands-on experience in GxP/GCP compliance, QMS, CAPA, deviations, change controls, and audit readiness.
• Solid understanding of ICHGCP, global regulatory requirements, and ethics committee norms.
• Experience with eQMS / QA tools.
• Familiar with risk assessment methodologies, root cause analysis tools, and quality metrics dashboards.
• Education: B.Pharm / M.Pharm / MSc in Life Sciences or related field.
• Certifications in GCP, QMS, or auditing are an advantage.
• Excellent communication, documentation, and analytical skills.
• Strong attention to detail, compliance mindset, and ability to work with global, cross-functional teams.
• Prior experience supporting regulatory inspections or client audits is highly desirable.
• Proactive, well-organized, and capable of managing deadlines and multiple priorities.
• Willingness to travel occasionally (if required).