Quality Assurance Manager

Role Overview

The Quality Assurance Manager also serves as the site's registered Company Pharmacist, which means holding both the strategic ownership of the quality management system and the legal accountability that comes with signing products off for the Kenyan market. Day to day, this role moves between authoring and approving GxP documentation, reviewing batch and analytical records, running inspections and audits, resolving complaints and recalls, and leading a QA team that keeps manufacturing operations compliant. It matters because nothing leaves the site without this position's approval, so the person in it is the final safeguard between production processes and the patients who receive the product.

Key Responsibilities

• Own, maintain and continually strengthen the Quality Management System so that it satisfies cGMP, GDP and GSP expectations and stays aligned with registered dossiers and applicable national and international regulations, including the timely preparation, review and approval of Product Quality Review reports.
• Act as the registered Company Pharmacist, releasing finished pharmaceutical products to market and carrying out every legal and regulatory duty attached to that registration.
• Authorise new and revised written procedures, covering SOPs, specifications, analytical methods, cleaning and operating instructions, validation, qualification and stability protocols, and batch and packaging instructions and records.
• Oversee calibration, qualification and validation activity across equipment, instruments, facilities, utilities, manufacturing processes and cleaning procedures, reviewing and approving the supporting documentation.
• Review batch, packaging and analytical testing records and make the approval or rejection decision on starting materials, packaging components, intermediates, bulk and finished products.
• Qualify, approve and continuously monitor manufacturers of raw materials, intermediates, packaging materials and finished products, and represent the company in external audits of vendors and service providers.
• Run scheduled self-inspections and internal audits, host inspections by regulatory authorities and customers, drive resulting CAPAs to timely closure, and manage market complaints and product recalls end to end with prompt responses to customers and regulators.
• Lead and develop the Quality Assurance team through functional and disciplinary leadership, ensure all staff receive regular and effective cGMP and GDP training, foster a strong quality culture across pharmaceutical operations, prepare and control the QA CAPEX and OPEX budget, and deputise for the QPPV when required.

Requirements & Qualifications

• Education: Bachelor of Pharmacy degree.
• Registration: Registered as a Pharmacist in the Republic of Kenya.
• Experience: A minimum of five years in the pharmaceutical industry, of which at least three years should have been spent in a comparable position.
• Regulatory knowledge: Expert-level understanding of local and international regulations and standards governing cGMP, GDP and GSP.
• Leadership and organisational skills: Demonstrated ability to lead teams, report clearly and structure work effectively, with the credibility to design procedures and influence colleagues as a team player.
• Working style: Self-driven and methodical, comfortable operating with minimal supervision, resolving problems quickly and performing well under sustained work pressure.
• Technical and language skills: Proficient in MS Word, MS Excel and MS PowerPoint, with strong command of written and spoken English.