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.
Positive IT skills, including Microsoft Word, Excel, and Outlook.

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