Operational Quality Advisor

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

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

You will support and lead operational quality activities across the Irvine site. You will work with site teams, regional quality colleagues and cross-functional partners to make sure our Quality Management System works in practice. We value clear communicators who build strong relationships and drive practical improvements. This role offers visible impact, learning and the chance to grow while supporting GSK’s mission of uniting science, technology and talent to get ahead of disease together.

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.

Why You?

This role is hybrid and based in the United Kingdom. Regular on-site presence and travel between sites will be required. We are looking for someone practical, curious and committed to continuous improvement. You will join a supportive team that values learning, collaboration and respect. We welcome applicants from all backgrounds and encourage you to apply.

Basic Qualification

• 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.

Preferred Qualification

• Experience working across multiple sites or within a matrix organisation.
• Background in sterile, complex or high-volume manufacturing environments.
• Familiarity with ERP, laboratory information systems or quality management software.
• Demonstrated delivery of continuous improvement and process simplification.
• Experience with stability programmes and product certification for multiple markets.

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.

We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.

Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Find out more on our career site.