Operational Quality Lead — GMP & CAPA

GlaxoSmithKline; Irvine; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

GSK Irvine site is seeking a capable quality professional to support and lead operational quality activities. You will work with site teams, regional quality colleagues and cross-functional partners to ensure our Quality Management System works in practice.

This role offers visible impact, learning and growth while supporting GSK’s mission to unite science, technology and talent to get ahead of disease together. This role is hybrid and based in the United Kingdom.

Qualifications

• Degree, HNC/HND or equivalent in a scientific, technical or engineering discipline, or equivalent practical experience.
• At least 3 to 5 years’ experience in manufacturing quality, operational quality or a related role in a regulated environment.
• Practical knowledge and application of Good Manufacturing Practice or equivalent regulatory standards.
• Experience with Quality Management Systems, batch review and release processes.
• Experience in investigations, root cause analysis and CAPA implementation.
• Strong oral and written communication, organisation and decision-making skills.

Responsibilities

• Review batch records, test results and stability data to support timely and compliant material release.
• Support and approve quality investigations, root cause analysis and CAPA implementation.
• Approve master batch instructions, specifications and site procedures to ensure regulatory and quality requirements are met.
• Lead operational quality approvals for changes and assess impacts on manufacturing, supply and compliance.
• Plan, conduct and document internal audits and targeted checks to assure Good Manufacturing Practice is followed.
• Drive quality improvement projects to simplify processes and raise right-first-time performance.
• Coach site teams, manage escalations of significant quality risks and support consistent application of the Quality Management System.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Degree, HNC/HND or equivalent in a scientific, technical or engineering discipline

Tools

ERP

Laboratory Information Systems

Quality Management Software

Job description

GSK Irvine site is seeking a capable quality professional to support and lead operational quality activities. You will work with site teams, regional quality colleagues and cross-functional partners to ensure our Quality Management System works in practice.

This role offers visible impact, learning and growth while supporting GSK’s mission to unite science, technology and talent to get ahead of disease together. This role is hybrid and based in the United Kingdom.