HEAD OF QUALITY - KENYA

Job Description: Head of Quality

Location: Kenya

Industry: Pharmaceutical Manufacturing

Job Overview:

• We are looking for an experienced Head of Quality to lead the Quality Assurance and Quality Control functions within a pharmaceutical manufacturing environment. The role will be responsible for ensuring product quality, regulatory compliance, and adherence to Good Manufacturing Practices (GMP).
• The ideal candidate will have strong expertise in pharmaceutical quality management systems, regulatory inspections, audits, validation, risk management, and team leadership.

Key Responsibilities:

• Develop, implement, and maintain quality policies, procedures, and robust quality management systems in line with WHO GMP, EU GMP, and other applicable regulatory requirements.
• Ensure compliance with statutory regulations, GMP, GxP, and internal quality standards.
• Act as the primary point of contact for all internal and external quality-related matters.
• Lead regulatory inspections and coordinate with external auditors and regulatory authorities.
• Report inspection outcomes to senior management and ensure timely closure of audit findings.
• Organize quality management review meetings with relevant stakeholders.
• Oversee product release approvals, batch documentation reviews, and quality-related decisions.
• Ensure adequate resources and competent personnel are available for quality review and approval activities.
• Authorize validation and qualification documents, SOPs, quality control specifications, and procedures.
• Lead quality risk management initiatives and implement corrective and preventive actions (CAPA).
• Review quality trends, deviations, out-of-specification results, complaints, and failures, and develop long-term corrective solutions.
• Oversee self-inspections, supplier audits, subcontractor audits, and audit programmes.
• Manage validation activities, including validation strategies, protocols, and reports.
• Develop, review, revise, and approve departmental SOPs and quality agreements.
• Ensure compliance with cGMP, GDocP, data integrity requirements, and ALCOA principles.
• Monitor departmental KPIs, budgets, costs, operational efficiency, and performance against business objectives.
• Prepare and manage the departmental budget, including resource and equipment requirements.
• Identify training needs and ensure effective induction and continuous training for quality personnel.
• Lead, mentor, and develop the quality team, including performance management and succession development.
• Monitor changes in regulatory legislation and communicate relevant updates to senior management.
• Coordinate product recall activities with relevant internal departments.
• Investigate discrepancies, errors, customer complaints, and adverse events, ensuring appropriate documentation and corrective action.
• Ensure all quality activities comply with health, safety, and applicable regulatory requirements.

Required Qualifications and Experience :

• Master's degree in a science-related field.
• Minimum 10 years of experience in Quality Assurance/Quality Control management, including at least 5 years in a senior management role.
• Proven experience in quality management within the pharmaceutical manufacturing industry.
• Training in manufacturing quality management systems.
• Strong knowledge of GMP and pharmaceutical regulatory requirements.
• A scientific degree, ideally in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related discipline.
• Demonstrated experience in a similar senior-level quality leadership position.
• Good IT skills, including Microsoft Word, Excel, and Outlook.