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Clinical Quality Assurance Manager

Auriga Research Private Limited
5-10 years
Not Disclosed
Gurgaon, India
1 June 1, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding

Clinical Quality Assurance Manager

Job Summary

The Clinical Quality Assurance Manager will lead quality assurance activities across clinical research programs, ensuring compliance with global regulatory requirements, company SOPs, and quality standards. The role requires leadership in audit management, quality systems oversight, and regulatory inspection readiness.

Key Responsibilities

  • Manage and maintain the Clinical Quality Management System.

  • Plan and conduct internal audits, vendor audits, and site audits.

  • Lead CAPA management and effectiveness reviews.

  • Ensure compliance with ICH-GCP, applicable regulations, and company SOPs.

  • Support regulatory inspections and sponsor audits.

  • Develop quality metrics, compliance reports, and management reviews.

  • Provide quality guidance to clinical operations and cross-functional teams.

  • Lead quality improvement initiatives and risk-based quality management activities.

  • Mentor and train quality and operational staff.

Qualifications

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Clinical Research, or related discipline.

  • Extensive experience in Clinical QA and GCP compliance.

  • Strong understanding of global regulatory requirements.

  • Proven leadership and audit management experience.