General Manager – Quality Assurance (Solid Oral Facility)

Job Purpose

To lead Quality Assurance operations for the Solid Oral facility and ensure compliance with cGMP, global regulatory requirements, data integrity standards, and Quality Management Systems.

Key Responsibilities

• Ensure compliance with cGMP, Data Integrity, and global regulatory requirements including USFDA, WHO-GMP, EU GMP, MHRA, PIC/S, TGA, and ANVISA.
• Lead Quality Management System (QMS) activities including deviations, OOS, CAPA, change control, market complaints, and investigations.
• Oversee batch review, approval, and release activities.
• Ensure qualification and validation of processes, equipment, utilities, cleaning, and computerized systems.
• Manage vendor qualification, quality agreements, artwork approvals, and risk assessments.
• Lead internal audits, self-inspections, customer audits, and regulatory inspections.
• Coordinate with Production, QC, Warehouse, Engineering,...