We are seeking a Senior QA Auditor/ Senior GCP Auditor professional with proven experience in audits, SOP management, and regulatory compliance across global clinical research environments.

This role is ideal for someone who has worked within or closely with a global CRO, understands the complexities of multi-country trial oversight, and can ensure all operations meet FDA, ICH-GCP, and 21 CFR Part 11 standards.

The successful candidate will serve as a key liaison between QA, Clinical Operations, and Regulatory Affairs—driving quality excellence, maintaining inspection readiness, and strengthening our Quality Management System (QMS) across all programs.

Key Responsibilities

• Lead and execute internal, external, vendor, and investigator site audits to ensure compliance with GCP and regulatory standards.
• Establish, maintain, and continuously improve the Quality Management System (QMS) across global studies and vendors.
• Serve as SOP owner for QA and compliance documentation—authoring, revising, and harmonizing procedures across business units.
• Manage SOP lifecycle processes, including creation, periodic review, deviation tracking, version control, and global rollout.
• Support regulatory inspection readiness (FDA, MHRA, EMA, DCGI, etc.) and act as QA representative during inspections.
• Lead CAPA investigations, ensuring timely and effective root cause analysis, remediation, and verification of effectiveness.
• Collaborate cross-functionally with Clinical Operations, Data Management, Biostatistics, and Regulatory teams to ensure compliance across all study phases.
• Provide compliance training and guidance to internal and external stakeholders, promoting a strong culture of quality and accountability.
• Monitor and interpret evolving global regulatory requirements, ensuring timely updates to SOPs and operational processes.
• Oversee vendor qualification, risk assessments, and QA oversight for global partners, CROs, and laboratories.

Qualifications

• Bachelor’s or advanced degree in Life Sciences, Quality Assurance, Regulatory Affairs, or related field.
• Experience with CSV ( Computer System Validation ) Audits
• 5–10 years of experience in Quality Assurance or Compliance roles within the clinical research industry, including experience with a CRO, pharma, or biotech organization.
• Deep understanding of FDA, ICH-GCP, HIPAA, and 21 CFR Parts 11, 50, 54, 56, 312, and 812.
• Proven success managing audits, inspections, and SOP systems across global clinical programs.
• Demonstrated ability to implement and maintain a robust QMS and drive continuous improvement initiatives.

Preferred Attributes

• Prior experience supporting multi-region clinical programs and global quality frameworks.

• Exceptional attention to detail, documentation discipline, and process ownership.

• Ability to translate regulatory standards into practical operational guidance.

• Comfortable leading in a fast-paced, inspection-ready, and globally distributed environment.