Head Of Operational Quality & Formulation
Job Type
Permanent
Location
Newcastle upon Tyne, Tyne and Wear
Negotiable
Job Ref
BBBH189230_1792172096
Date Added
October 16th, 2026
Consultant
nathan fairhurst
Head of Operational Quality & Formulation
Location: Northeast England
SRG are partnered with an established pharmaceutical manufacturer in the Northeast to find a Head of Operational Quality and Formulation. The company are leaders in the manufacture of Specials, supplying hard-to-source products to the patients who need them.
This is a key technical, quality leadership position overseeing the quality and timely release of life saving products.
The Role
As the head of Operational Quality & Formulation, you will be lead the Quality and Formulation teams ensuring the quality & compliance of manufactured Specials products allowing them to reach the patients who need them.
Key duties will include:
- Oversight of the product release processes, stability monitoring programmes, and compliance systems across manufacturing operations.
- Acting as Quality Controller on the Manufacturers' Specials License for the site in line with MHRA requirements.
- Overseeing quality teams and processes to ensure timely release of products in compliance with GMP, internal SOPs, and regulatory standards.
- Monitoring key quality release metrics, including batch release timelines, right-first-time rates, and turnaround times for issue resolution.
- Leading monthly performance reviews, contributing to site-level Quality Manager Review forums, and identifying bottlenecks to streamline batch review workflows.
- Managing new product introductions from technical feasibility to production readiness, including working with procurement on starting materials and formulations.
- Designing and overseeing stability programs, owning product lifecycle data, and leading root cause investigations and CAPAs.
- Maintaining compliance with GMP, GDP, and MHRA regulations, supporting audits, and contributing to product quality reviews and change controls.
Requirements
- Registration with the General Pharmaceutical Council (GPhC) is essential.
- Proven experience in a similar position within pharmaceutical formulation, QA, or manufacturing.
- Excellent knowledge of GMP, GDP, and MHRA Specials guidance.
- Experience in deviation investigations, risk assessments, and change control management.
We believe in the power of science - that's why we stay at the forefront of the life sciences industry, keeping up to date with the latest research, innovations, and market trends to provide valuable insight and guidance to our clients and candidates.
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Head Of Operational Quality & Formulation in Newcastle upon Tyne employer: SRG
As a Senior Clinical Trial Manager at our company, you will thrive in a dynamic and collaborative work environment that prioritises innovation and employee development. We offer competitive benefits, a strong focus on professional growth, and the opportunity to work alongside industry leaders in a location renowned for its commitment to advancing clinical research. Join us to make a meaningful impact in the field of clinical trials while enjoying a supportive culture that values your contributions.
