About the role
Role OverviewWe 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 ResponsibilitiesLead 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 validationEnvironmental MonitoringContamination Control Strategy (CCS)Review and approve:Batch Manufacturing Records (BMRs)Deviations, OOS, OOT, and CAPAsChange controls and risk assessmentsProvide QA oversight for:Equipment, process, cleaning, and computer system validationData integrity compliance in line with ALCOA+ principlesLead 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.
Qualifications & ExperienceBachelor’s degree in Pharmaceutical Science.Minimum 15 years of experience in pharmaceutical manufacturing.At least 10 years in a QA leadership role within sterile manufacturing.In-depth knowledge of EU GMP Annex 1 requirements.Excellent leadership, communication, and decision-making skills. Key CompetenciesStrong regulatory and inspection readiness mindset.Risk-based thinking and strong root cause analysis skills.Ability to work effectively under pressure and manage critical situations.
