Job Title: Head of Quality
Job Purpose
As Head of Quality, you will serve as the Management Representative for Quality, taking full accountability for an effective Pharmaceutical Quality System (PQS) that safeguards patient safety, product quality, and regulatory compliance across the group. You will establish the quality agenda and foster a culture of quality excellence, continuous improvement, data integrity, and inspection readiness throughout the organization.
Key Responsibilities
- Strategic Leadership: Define and deliver the company’s Quality Strategy in alignment with corporate objectives.
- Pharmaceutical Quality System (PQS) Ownership: Lead and drive continuous improvement of the PQS to ensure it remains robust and effective.
- Oversight of QA/QC Functions: Direct the Quality Assurance and Quality Control departments, ensuring full compliance with PIC/S GMP, applicable regional GMP standards, and ISO requirements.
- Batch Disposition Authority: Act as the final quality authority for batch disposition and product release decisions.
- Regulatory Engagement: Lead regulatory inspections and audits, serving as the primary point of contact for all quality-related interactions with regulators.
- Risk Management & Data Integrity: Drive the application of quality risk management principles and ALCOA++ data integrity practices across products, processes, and suppliers.
- Team Development: Lead, coach, and develop high-performing QA and QC teams to achieve excellence in quality operations.
Educational Background & Career Experience
- 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 of pharmaceutical industry experience, with at least 8 years in a senior quality leadership role.
- Proven experience leading both QA and QC functions within GMP manufacturing environments.
- A track record of successfully managing regulatory inspections and audits; multi-site experience is highly desirable.
- Strong leadership, strategic thinking, decision-making, and stakeholder management skills.
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