Operational Quality Advisor

Overview

In this role you drive operational quality at the Irvine site, ensuring the Quality Management System works in practice across site teams and partners. You will influence process changes and quality decisions that affect manufacturing, release, and compliance. You’ll lead investigations, CAPA and internal audits, and mentor teams to improve right-first-time performance. This role offers visible impact within a collaborative, continuous-improvement culture and supports GSK’s mission to bring innovative medicines to patients.

Responsibilities

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

Key requirements

• Degree, HNC/HND or equivalent in a scientific, technical or engineering discipline; or equivalent practical experience
• 3–5 years’ experience in manufacturing quality, operational quality or a related regulated role
• Practical knowledge of Good Manufacturing Practice or equivalent 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

• Practicality
• Curiosity
• Collaboration
• Good Manufacturing Practice (GMP) knowledge
• Quality Management Systems
• Batch review and release processes

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