Head of Quality (Pharma)

Qualifications, Skills and Experience Minimum Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific field. hat is Minimum 10 years of experience in QA/QC management, including at least 5 years in a senior management role. Proven experience in quality management within the pharmaceutical manufacturing industry. Strong knowledge of WHO GMP, EU GMP, cGMP, regulatory compliance, and pharmaceutical quality management systems. Experience in regulatory inspections, audits, CAPA, validation, quality risk management, and product release processes. Strong leadership, strategic planning, analytical, problem-solving, and stakeholder management skills. Excellent communication, organizational, and team management abilities. Proficiency in Microsoft Office and quality reporting systems. Key Responsibilities Develop and implement quality policies, strategies, SOPs, and quality management systems in compliance with WHO GMP, EU GMP, and regulatory requirements. Oversee QA/QC operations, product quality, batch documentation, and final product release or rejection. Lead internal audits, self-inspections, supplier audits, and regulatory inspections, ensuring timely closure of findings and CAPA implementation. Manage validation, qualification, quality risk assessments, investigations, deviations, complaints, and product recalls. Ensure compliance with cGMP, GDocP, data integrity principles (ALCOA), and applicable statutory requirements. Monitor quality performance, compliance trends, departmental KPIs, budgets, and continuous improvement initiatives. Lead, train, and develop quality teams while ensuring effective resource planning and departmental performance. Coordinate with senior management, regulatory authorities, external auditors, and internal departments on quality and compliance matters.