Clinical Quality Assurance Manager

Key Responsibilities & Required Qualifications::

• Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related discipline.
• 7+ years of experience in Pharmaceutical QA, Quality Operations, or a GMP-regulated environment.
• Hands-on experience with clinical packaging and labeling operations.
• Strong experience reviewing and approving clinical packaging/labeling batch records.
• Knowledge of GMP regulations, deviations, CAPAs, investigations, and change controls.
• Experience working with Contract Manufacturing Organizations (CMOs) and external vendors.
• Provide QA oversight of clinical packaging and labeling activities at external CMOs.
• Review and approve batch records, master batch records, label proofs, and related GMP documentation.
• Manage deviations, investigations, CAPAs, change controls, and product impact assessments.
• Oversee CMO quality performance, vendor compliance, quality agreements, and audit readiness.
• Collaborate with Clinical Supply Chain, CMC, Regulatory Affairs, and Clinical Operations.
• Ensure GMP compliance, data integrity, inspection readiness, and continuous process improvement.