Senior Quality & Formulation Leader — GMP/MHRA (Pharma)

SRG; Newcastle upon Tyne; On-site; GBP 90,000 - 120,000; Full time

Job summary

SRG in the Northeast of England is seeking a Head of Operational Quality & Formulation to lead the Quality and Formulation teams, ensuring GMP-compliant release of Specials products. You will oversee product release processes, stability programmes, and MHRA compliance, driving timely release and continuous improvement while partnering with procurement on starting materials and formulations.

Registration with the GPhC is essential.

Qualifications

• Registration with the General Pharmaceutical Council (GPhC) is essential.
• Proven experience in pharmaceutical formulation, QA, or manufacturing.
• Excellent knowledge of GMP, GDP, and MHRA Specials guidance.
• Experience in deviation investigations, risk assessments, and change control management.

Responsibilities

• Oversee quality release, stability monitoring, and compliance across operations.
• Act as Quality Controller on MHRA Specials license for the site.
• Lead quality teams to ensure timely product release per GMP and SOPs.
• Monitor batch release timelines, right-first-time rates, and issue resolution turnaround.
• Lead monthly performance reviews and improve batch review workflows.
• Manage new product introductions from feasibility to production readiness.
• Design and oversee stability programs and root cause investigations.
• Ensure GMP, GDP, MHRA compliance and support audits and change controls.

Education

GPhC registration

Job description

SRG in the Northeast of England is seeking a Head of Operational Quality & Formulation to lead the Quality and Formulation teams, ensuring GMP-compliant release of Specials products. You will oversee product release processes, stability programmes, and MHRA compliance, driving timely release and continuous improvement while partnering with procurement on starting materials and formulations.

Registration with the GPhC is essential.