Head Of Operational Quality & Formulation

Overview

In this role you will lead the Quality and Formulation functions to guarantee the quality and timely release of life-saving Specials. You will work within a cross-functional team to uphold GMP, GDP, and MHRA standards, ensuring compliant product release and lifecycle management. You shape quality strategies for new product introductions and stability programs, driving continuous improvements in release performance. This position offers a meaningful opportunity to impact patient access to critical therapies and strengthen regulatory readiness across the site.

Responsibilities

• Oversee product release processes and stability monitoring programs across manufacturing operations
• Act as Quality Controller on the site’s Specials licensure per MHRA requirements
• Ensure timely product release in compliance with GMP, internal SOPs, and regulatory standards
• Monitor key quality release metrics (batch release timelines, right-first-time rates, issue resolution turnaround)
• Lead monthly performance reviews and identify bottlenecks to streamline batch review workflows
• Manage new product introductions from feasibility to production readiness, coordinating with procurement on starting materials and formulations
• Design and oversee stability programs, own product lifecycle data, and lead root cause investigations and CAPAs
• Maintain GMP, GDP, MHRA compliance, support audits, and contribute to change controls and quality reviews

Key requirements

• GPhC registration essential
• Proven experience in pharmaceutical formulation, QA, or manufacturing
• Strong knowledge of GMP, GDP, and MHRA Specials guidance
• Experience in deviation investigations, risk assessments, and change control management

• GMP
• GDP
• MHRA Specials guidance
• Deviation investigations
• Risk assessments
• Change control management

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