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.
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Head of Quality 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.
