Head of Quality (Pharma)

Role Overview

This senior quality leader sets the standards and systems that guide quality assurance and quality control across pharmaceutical manufacturing. The role oversees product quality from documentation review through release decisions, while preparing the organisation to meet regulatory expectations and address quality issues effectively.

Key Responsibilities

• Establish and maintain quality policies, procedures, and management systems aligned with WHO GMP, EU GMP, cGMP, and relevant regulatory requirements.
• Direct QA and QC activities, review batch records and product quality information, and make release or rejection decisions in accordance with approved procedures.
• Plan and lead internal audits, self-inspections, supplier audits, and regulatory inspections; track observations through to timely corrective and preventive action.
• Oversee validation and qualification work, quality risk assessments, investigations, deviations, customer complaints, and product recall activities.
• Promote compliance with Good Manufacturing Practice, Good Documentation Practice, ALCOA data integrity principles, and applicable statutory requirements.
• Review quality performance, compliance trends, and departmental KPIs; manage budgets and identify practical opportunities for continuous improvement.
• Lead and develop quality personnel, setting team priorities and ensuring appropriate resource planning and departmental performance.
• Coordinate quality and compliance matters with senior management, regulatory authorities, auditors, and other internal departments.

Requirements & Qualifications

• Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
• At least 10 years of experience in QA/QC management, including a minimum of 5 years in a senior management position.
• Demonstrated quality management experience in pharmaceutical manufacturing.
• Strong working knowledge of WHO GMP, EU GMP, cGMP, regulatory compliance, and pharmaceutical quality management systems.
• Practical experience with regulatory inspections and audits, CAPA, validation, quality risk management, and product release processes.
• Leadership, strategic planning, analytical, and problem-solving capabilities, with the judgement to manage stakeholders across the organisation.
• Strong communication, organisation, and team management skills.
• Proficiency with Microsoft Office and quality reporting systems.