Job Purpose
As Head of Quality, you will be the Management’s Representative for Quality — accountable for an effective Pharmaceutical Quality System (PQS) that safeguards patient safety, product quality and regulatory compliance across the group. You will set the quality agenda and drive a culture of quality excellence, continuous improvement, data integrity and inspection readiness throughout the organization.
Roles and Responsibilities
- Quality Strategy: Set and deliver the company's Quality Strategy, aligned to corporate objectives.
- System Management: Lead and continuously improve the Pharmaceutical Quality System (PQS).
- Standards & Compliance: Oversee the Quality Assurance and Quality Control functions, ensuring compliance with PIC/S GMP, applicable regional GMP and ISO standards.
- Product Release: Act as final quality authority for batch disposition and product release.
- Audits & Inspections: Lead regulatory inspections and audits, serving as the primary quality contact.
- Risk Management & Data Integrity: Drive quality risk management and ALCOA++ data integrity across products, processes and suppliers.
- Leadership: Lead, coach and develop high-performing QA and QC teams.
Educational Background & Career Experience
- A Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Engineering or a related discipline.
- Registered Pharmacist with the Pharmacy and Poisons Board (PPB) Kenya.
- Minimum 10 years' pharmaceutical industry experience, including at least 8 years in senior quality leadership.
- Proven experience leading both QA and QC functions within GMP manufacturing environments.
- Track record of managing regulatory inspections and audits; multi-site experience highly desirable.
- Strong leadership, strategic thinking, decision-making and stakeholder management skills.
