Quality Assurance Manager (Pharmaceutical)

Mission:The QAM maintains and improves the Quality Management System (QMS), ensuring all commercialized products follow GSP and regulatory standards. A primary focus is overseeing Quality aspects of products produced by Contract Manufacturing Organizations (CMO) to ensure adherence to EU-GMP guidelines, regulatory filings, and Quality Technical Agreements.
Responsibilities
• QMS & Documentation: Establish and improve the QMS in compliance with GSP. Review batch records, SOPs, and validation protocols to ensure data integrity.
• CMO Oversight: Actively monitor third-party manufacturer performance through site visits, data reviews, and management of Quality Technical Agreements.
• Batch Release: Review and approve Batch Manufacturing Records (BMRs) and analytical data. Provide final authorization for finished product market release.
• Validation & Tech Transfer: Oversee technology transfer activities, process validation batches, and stability data consistency.
• Deviation & CAPA: Lead investigations into deviations, non-conformances, customer complaints and significant quality events. Conduct Root Cause Analysis (RCA) and implement effective CAPAs.
• Audits & Change Control: Lead internal and supplier audits. Conduct on-site audits and compliance visits to ensure adherence to GMP, SOPs, and regulatory requirements. Manage impact assessments and approve changes in materials, equipment, or manufacturing processes at the toll sit
• Leadership & KPIs: Manage the QA team, providing mentorship, training and setting quality objectives for the organization. Monitor, analyze and report quality metrics/KPIs to senior management.