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Head of Operational Quality and Formulation

Quantum Pharmaceutical
£56,135 - £71,080 a year
County Durham, England
Full time
1 day ago

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

As part of our Group, Quantum Pharmaceutical is the UK’s leading 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—we are one of the fastest-growing healthcare companies in the UK.

We are currently seeking a passionate Head of Operational Quality and Formulation to join our Aseptic Services team, a key part of our operations, where we manufacture life-saving chemotherapy drugs.

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

  • Overseeing 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 Manufacturers Specials License for the Burnopfield manufacturing site in line with MHRA requirements
  • Establish, monitor and report on key quality related release metrics including:
    • Batch release timelines and adherence t SLA.
    • Right-First-Time (RFT) release rates.
    • Turnarund time for resolution of batch release issues.
    • Lead mnthly performance reviews and contribute to site-level Quality Manager Review (QMR) forums.
    • Identify bttlenecks and lead initiatives to streamline batch documentation, review workflows and reduce release cycle time.
    • Implement and track cntinuous improvement projects using structured methodologies.
    • Cllaborate with Production, Warehouse, training and QA 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 programs 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 MHRA Regulations
  • Support audits and contribute to 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 MHRA Specials guidance.
  • Excellent communication, leadership, and project coordination skills.
  • Strong data analysis and process improvement mindset.
  • Comfortable working in fast-paced, regulated, multi-site environments.
  • Experience of operating in a similar role is desirable.

Why Join Us?

Career Growth - Elevate your expertise in a fast-growing, cutting-edge industry

Flexible Shifts – Between our 24-hour core operating hours, Monday – Sunday

Pension & Benefits – Including a cycle-to-work scheme

Free Food & Drinks – Enjoy complimentary refreshments at work

Vibrant Work Culture – A strong Social Committee organises regular events

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