Head of Quality

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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