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:
Set and deliver the company's Quality Strategy, aligned to corporate objectives.
Lead and continuously improve the Pharmaceutical Quality System (PQS).
Oversee the Quality Assurance and Quality Control functions, ensuring compliance with PIC/S GMP, applicable regional GMP and ISO standards.
Act as final quality authority for batch disposition and product release.
Lead regulatory inspections and audits, serving as the primary quality contact.
Drive quality risk management and ALCOA++ data integrity across products, processes and suppliers.
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.