Job
Description
Quality Manager Pharmaceutical Manufacturing Department: Quality Specialist Reports to: Director Job Summary: We are seeking a highly competent and detail-oriented Quality Manager to lead the Quality Assurance and Quality control functions at our pharmaceutical manufacturing site. The successful candidate will bring deep knowledge of WHO GMP, PICS standards, and EU GMP regulatory expectations, ensuring full compliance and continuous improvement of the Quality Management System (QMS). Key Responsibilities: • Lead, manage, and continuously improve the Quality Management System (QMS) to ensure full compliance with WHO, PICS, and EU GMP regulatory requirements. • Oversee GMP compliance, including batch record review, deviation management, CAPAs, change control, product release, OOS, OOT and risk assessments. • Act as the site representative during inspections and audits (WHO PQ, EU GMP, PICS, clients), including preparation, hosting, and follow-up. • Supervise and mentor QA / QC teams responsible for documentation control, training, and GMP compliance. • Develop and implement cleaning validation, Process validation, Equipment qualification and utility qualification activity. • Review and approve critical quality documents such as SOPs, protocols, reports, and validation master plans. • Oversee the vendor qualification and quality agreements with external suppliers, service providers, and contract manufacturers. • Lead internal audits and support continuous quality improvement initiatives. • Collaborating with cross-functional teams to ensure quality throughout the product lifecycle. • Developing and implementing quality control systems. • Monitoring performance of quality control processes. • Analyzing quality data to identify areas for improvement. Qualifications & Experience: • Bachelors or Masters degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or related life sciences field. • Minimum of 8 years of pharmaceutical quality experience, with 3+ years in a managerial or leadership role. • In-depth knowledge of WHO GMP, PICS guidelines, and European regulatory requirements. • Strong experience leading audits/inspections from international authorities (e.g., WHO, PICS, EU) • Excellent analytical, leadership, and interpersonal skills. • Fluent in English
