Role Overview We are seeking an experienced Quality Assurance Manager – Sterile Manufacturing to lead and manage the QA function, ensuring full compliance with EU GMP, cGMP, and WHO guidelines. The role is critical in maintaining an effective Pharmaceutical Quality System (PQS) and ensuring sterility assurance across manufacturing operations. Key Responsibilities Lead and manage the Quality Assurance department in compliance with EU GMP, cGMP, and WHO guidelines. Ensure full implementation, maintenance, and continuous improvement of the Pharmaceutical Quality System (PQS). Oversee sterility assurance activities, including: Process validation Environmental Monitoring Contamination Control Strategy (CCS) Review and approve: Batch Manufacturing Records (BMRs) Deviations, OOS, OOT, and CAPAs Change controls and risk assessments Provide QA oversight for: Equipment, process, cleaning, and computer system validation Data integrity compliance in line with ALCOA+ principles Lead and actively participate in regulatory inspections and audits. Manage supplier qualification, audits, and quality agreements. Develop, review, and maintain SOPs, policies, and quality documentation. Lead QA team training, performance evaluation, and continuous improvement initiatives.