Director of Quality Assurance

Overview

In this role you will lead the site Quality Assurance function within a leading Pharma Services organisation. You will own the Pharmaceutical Quality System, ensure full regulatory compliance, and drive continuous improvement. You will liaise with regulatory authorities, lead inspections, and shape quality strategy at site level. The position offers strategic influence, cross-functional collaboration, and the opportunity to impact client projects and business objectives. You will work with global teams to enhance quality systems and support business development.

Responsibilities

• Lead and develop the Quality Assurance function aligned to business needs
• Own and maintain the Pharmaceutical Quality System (PQS) in line with global standards and regulatory requirements
• Act as primary contact for regulatory authorities, leading inspections and representing the site externally
• Provide QA oversight across site operations ensuring GMP and regulatory expectations are met
• Drive operational performance within QA to deliver on client commitments and timelines
• Identify and implement improvements to quality systems and processes with global teams
• Support business development by providing QA input into opportunities and partnerships

Key requirements

• Degree educated in a scientific discipline with eligibility to act as a Qualified Person (QP)
• Significant experience in a Senior Operational Quality role within the pharmaceutical industry, including QP responsibilities
• Proven experience leading teams and managing QA functions in a GMP-regulated environment

• Leadership and people management
• Stakeholder engagement and regulatory liaison
• Strategic thinking and problem solving
• GMP regulatory knowledge
• Pharmaceutical Quality System (PQS) management
• QP eligibility and responsibilities

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