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Vacancy description

Associate Director, Country Clinical Quality Manager (CCQM) India in Gurgaon, भारत

Merck

Gurgaon, भारत

Merck seeks an Associate Director to lead clinical quality management across India operations. This role oversees regulatory compliance, quality control activities, training coordination, audit management, and process improvements aligned with ICH-GCP standards and local regulations.

Responsibilities

  • Serve as local expert for ICH-GCP compliance and local regulatory requirements with impact assessment capability
  • Coordinate and oversee quality control activities including in-house quality control plans and quality control visits
  • Manage audit and inspection preparation, execution, and follow-up; lead CAPA tracking and root-cause analysis
  • Identify process gaps and lead continuous quality improvements at country and regional levels
  • Coordinate supplier qualifications and manage local training needs in collaboration with L&D

Requirements

  • Bachelor's degree in pharmaceutical, nursing, biotechnology, or related healthcare field
  • 10-12 years total experience with minimum 6-8 years direct clinical research and trial operations
  • Clinical research field monitoring or CRA experience preferred
  • Deep knowledge of clinical trial processes, GCP, and clinical research regulations
  • Demonstrated experience in clinical quality management, audits, inspections, and process improvement
  • Project management expertise and proven ability to lead cross-functional teams
  • Proficiency in AI, data analytics, and automation for quality management optimization

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