Quality Manager - clinical trial - Pharma industry

Key ResponsibilitiesManage and maintain the Quality Management System (QMS).Lead CAPA, deviations, investigations, and change control processes.Ensure compliance with GMP, cGMP, and GDP standards.Provide quality oversight for clinical packaging, labeling, storage, and distribution.Support FDA inspections, audits, and regulatory compliance activities.Maintain SOPs, quality documentation, and quality metrics.Collaborate with cross-functional teams across warehouse and clinical supply operations.Requirements5+ years of QMS experience in the pharmaceutical industry.Mandatory experience in CAPA, GMP, and cGMP environments.Knowledge of GDP regulations and quality systems.Experience with clinical packaging & labeling under 21 CFR 210/211.Experience supporting FDA inspections or audits is a plus.Familiarity with SAP and MS Office.