Head Of Operational Quality & Formulation

SRG; Newcastle upon Tyne; On-site; GBP 85,000 - 125,000; Full time

Job summary

SRG is partnering with a pharmaceutical manufacturer in the Northeast to appoint a Head of Operational Quality and Formulation. The role leads QA and Formulation teams, ensuring quality and timely release of life-saving Specials products.

You will oversee product release processes, stability programmes, and regulatory compliance (GMP, GDP, MHRA). The position requires GPhC registration and a proven track record in pharmaceutical QA or formulation leadership, with a focus on continuous

Qualifications

• GPhC registration is essential.
• Proven experience in pharmaceutical QA/formulation or manufacturing.
• Excellent knowledge of GMP, GDP, and MHRA Specials guidance.
• Experience in deviation investigations, risk assessments and change control management.

Responsibilities

• Oversee product release processes and stability monitoring programmes.
• Act as Quality Controller for MHRA Specials License compliance.
• Ensure timely release of products in line with GMP, SOPs and regulatory standards.
• Monitor release metrics: batch release timelines, right-first-time rates and issue turnaround times.
• Lead monthly performance reviews and drive bottleneck removal in batch review workflows.
• Manage new product introductions from feasibility to production readiness, liaising with procurement on starting materials and formulations.
• Design and oversee stability programs, own lifecycle data, and lead CAPA investigations.
• Maintain GMP, GDP compliance, support audits and contribute to quality reviews and change controls.

Skills

GPhC registration

GMP/GDP knowledge

QA leadership

Deviation investigations

Job description

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.

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