Sector: PharmaceuticalsReference: BBBH189230_1792172096Head of Operational Quality & FormulationLocation: 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 productsThe 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. RequirementsRegistration 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.Guidant, Carbon60, Lorien & SRG - The Vertage Group Portfolio are acting as an Employment Business in relation to this vacancy.
Head Of Operational Quality & Formulation employer: SRG Talent
As a leading pharmaceutical development and manufacturing organisation based in central Scotland, we pride ourselves on fostering a collaborative work culture that prioritises compliance and quality. Our employees benefit from an excellent package that includes enhanced pension, healthcare, and flexible working hours, alongside ample opportunities for professional development and growth within the industry. Join us to be part of a team that values your contributions and supports your career aspirations in a meaningful way.
