Head of Quality and Formulation Operations

Are you looking for a rewarding career in healthcare manufacturing? Join a pioneering pharmaceutical developer and manufacturer dedicated to innovation and saving lives.

As part of a growing healthcare group, this organisation is a leading UK manufacturer and supplier of unlicensed medicines and hard-to-source products. With over 500 professionals across various disciplines—including pharmacists, technicians, IT, HR, procurement, warehouse, and customer service—it is one of the fastest-growing healthcare companies in the UK.

We are currently seeking a passionate Head of Operational Quality and Formulation to join the Aseptic Services team, a key part of operations where life-saving chemotherapy medicines are manufactured.

Why This Role Matters

This isn’t just a job—it’s an opportunity to make a real difference. You’ll be part of a team that values growth, innovation, and professional development.

Your Responsibilities

Product Release

• Oversee processes, policies and quality teams to ensure timely and safe release of manufactured products in compliance with GMP, internal SOPs and regulatory standards.

• Act as Quality Controller on the Manufacturer’s Specials Licence for the manufacturing site in line with regulatory requirements.

• Establish, monitor and report on key quality-related release metrics including:

  • Batch release timelines and adherence to SLA

  • Right-First-Time (RFT) release rates

  • Turnaround time for resolution of batch release issues

• Lead monthly performance reviews and contribute to site-level Quality Management Review (QMR) forums.

• Identify bottlenecks and lead initiatives to streamline batch documentation, review workflows and reduce release cycle time.

• Implement and track continuous improvement projects using structured methodologies.

• Collaborate with Production, Warehouse, Training and QA teams to improve coordination and reduce repeat errors.

Formulation and Product Introduction

• Manage and guide new product introduction from technical feasibility to production readiness.

• Liaise with production and procurement teams to assess and control new starting materials and formulations.

• Act as a superuser for the electronic manufacturing system to ensure formulations are developed and manufactured according to GMP, internal SOPs and regulatory standards.

Stability and Lifecycle

• Design and oversee stability programmes in alignment with regulatory requirements.

• Own and monitor product lifecycle data.

• Lead root cause investigations and implement CAPAs related to formulation and product performance.

• Ensure pharmacovigilance systems are in place and monitor adherence.

Quality Systems and Compliance

• Lead deviation investigations, customer complaint assessments, risk assessments and change controls as required.

• Maintain and update SOPs, protocols and technical documentation.

• Ensure compliance with GMP, GDP and relevant regulatory requirements.

• Support audits and contribute to Product Quality Reviews (PQRs), product recalls and QMS reviews.

What We’re Looking For

• GPhC registration is essential.

• Minimum 5 years’ experience in pharmaceutical formulation, QA, or manufacturing.

• Strong knowledge of GMP, GDP and regulatory guidance relating to Specials manufacturing.

• Excellent communication, leadership and project coordination skills.

• Strong data analysis and process improvement mindset.

• Comfortable working in fast-paced, regulated, multi-site environments.

• Experience operating in a similar senior quality or formulation leadership role is desirable.