Information
* Job Ref: JM1381015QuaHOOQAF
* Location: Quantum House, Hobson Industrial Estate, Burnopfield
* Postcode: NE16 6EA
* Type of contract: Permanent
* Posted Date: Sunday, August 24, 2025
* Closing Date: Friday, September 19, 2025
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Overview
Head of Operational Quality and Formulation
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.
Responsibilities
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:
o Batch release timelines and adherence to SLA.
o Right-First-Time (RFT) release rates.
o Turnaround time for resolution of batch release issues.
o Lead monthly performance reviews and contribute to site-level Quality Manager Review (QMR) forums.
o Identify bottlenecks and lead initiatives to streamline batch documentation, review workflows and reduce release cycle time.
o Implement and track continuous improvement projects using structured methodologies.
o Collaborate 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
Apply
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