QUALITY HEAD

Job Description : QUALITY HEAD DRC FOR PHARMA a leading pharmaceutical manufacturer in the Democratic Republic of Congo, with a strong domestic position and an expanding portfolio of essential medicines. Quality assurance (QA) and quality control (QC) are being brought together under a single leader, and the company is looking for a Head of Quality Unit to take that role. This is the senior quality authority on site. You would report to the General Manager, lead a QA and QC team of around ten people, and own the effectiveness of the site's Pharmaceutical Quality Management System (PQMS). The role carries real decision-making power with it: you can block or reject materials and batches, and you can stop good manufacturing practice (GMP) activities where product quality, compliance or patient safety is genuinely at risk. Why the role is open now: The two positions that previously covered QA and QC separately are being combined into one Quality Unit. Site management is currently covering quality alongside other responsibilities, so our client wants a dedicated leader in place who can give the function its full attention. The timing matters. The company is preparing application files for marketing authorisation and for approval by the United States Food and Drug Administration, the product range is growing, the QA and QC team is expected to grow with it, and a second factory is planned. Whoever takes this role now will shape how quality works at the site as it scales. What you would work on in the first year: Assess how mature and effective the PQMS really is, then strengthen it where the assessment says it needs strengthening. Close the gap between what the procedures describe and what happens on the factory floor. Establish a regular programme of internal audits and self-inspections, and keep the site permanently ready for inspection. Improve deviations, corrective and preventive action (CAPA), change control, out of specification (OOS) and out of trend (OOT) handling, and raise the standard of investigations and effectiveness checks. Strengthen batch review and release, data integrity and ALCOA+ practice, validation and qualification, and supplier qualification. Improve QC laboratory performance: method control, analytical turnaround time, testing backlog and equipment availability. Put meaningful quality indicators, trend reviews and management reporting in place. How the role works day to day: You would spend more than half of your working week in the production, warehouse and laboratory areas, with much of the remaining time on quality control and batch release, and the rest on training and building capability in the team. You would work closely with Production, Research and Development, Engineering and Maintenance, Supply Chain and Procurement, Warehouse, Regulatory Affairs, health and safety, and site management. Externally, the role deals with health authorities, certification bodies, customers, suppliers, external laboratories and international partners, with occasional travel for audits, inspections, conferences and training. The quality team today is strong on procedures and documentation. What the company wants next is a leader who is present with the teams, who brings other functions into shared ownership of quality, who stays calm and flexible during audits and inspections, and who is rigorous about the things that cannot move. Changing how people think about quality is as much a part of this job as improving the systems behind it. What you need to bring: French at professional proficiency A university degree in pharmacy, pharmaceutical sciences, chemistry, biochemistry, chemical engineering, biology or another relevant scientific discipline. Eight to ten years or more in the pharmaceutical industry, in a GMP manufacturing environment. API manufacturing experience. This is the one requirement with no flexibility in it. Significant hands-on experience across both QA and QC. Strong practical GMP knowledge, including ICH Q7 and the applicable European Union and World Health Organization GMP requirements. Proven experience leading and developing quality teams, including the confidence to challenge production when quality requires it. Real depth in deviations, CAPA, change control, OOS and OOT, and quality investigations. Experience of GMP inspections, customer and supplier audits, and direct interaction with regulatory authorities. Qualification and validation experience covering equipment, utilities, processes, cleaning and analytical methods. Pharmaceutical laboratory and analytical testing management experience. Strong GMP documentation and data integrity practice. Location, package and commitment: The role is based on in the east of the Democratic Republic of Congo. Because the next few years are a critical period for the site, the company is looking for someone who can commit to a minimum of around 3 years. Responsibility and package are expected to grow as the site and the quality function grow.

---