General Manager

Job Description : General Manager (Quality) – Pharma Industry KENYA Industry: Pharmaceutical Manufacturing Designation: General Manager – Quality (QA/QC) Experience:20+ years Senior Quality Leadership Experience in Pharma Industry We are looking for an experienced General Manager – Quality to lead and manage the QA & QC functions for a reputed pharmaceutical manufacturing organization. The role requires strong leadership in quality systems, regulatory compliance, audits, and ensuring product quality standards across manufacturing operations. Key Responsibilities Lead and manage the Quality Assurance (QA) and Quality Control (QC) departments. Ensure compliance with GMP, regulatory guidelines, and quality standards. Develop and implement robust quality management systems (QMS). Drive continuous improvement initiatives across quality processes. Manage regulatory inspections and customer audits (WHO-GMP, USFDA, EU, etc.). Ensure adherence to SOPs, validation protocols, CAPA, deviations, change controls, and risk assessments. Review and approve quality documentation including batch records, investigations, and product release activities. Oversee QC operations including analytical testing, stability studies, method validation, and laboratory compliance. Provide strategic direction to quality teams and build a strong quality culture. Collaborate with Production, Regulatory Affairs, Engineering, and Supply Chain teams for quality excellence. Ensure timely closure of audit observations and compliance-related actions. Monitor quality KPIs and present quality performance reviews to management. Candidate Profile Bachelor’s / Master’s degree in Pharmacy (B.Pharm / M.Pharm) preferred. Strong experience in Pharmaceutical Manufacturing Quality (QA/QC). Proven experience handling large QA & QC teams. Experience in regulatory audits and compliance management. Strong knowledge of GMP, GLP, GDP, and pharmaceutical quality systems. Excellent leadership, decision-making, and problem-solving skills.

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