Operational Quality Advisor

GSK; Rawmarsh; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

GSK is seeking a results-driven quality professional to lead operational quality activities at our Irvine site. You will ensure the Quality Management System is applied in practice, driving improvements and supporting timely material release.

You will review data, lead investigations, CAPA, and master batch instruction approvals while collaborating with cross-functional teams to maintain regulatory compliance and consistency across sites.

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

Degree/HNC/HND

Experience in manufacturing quality

GMP knowledge

QMS knowledge

Investigations & CAPA

Communication & writing

Batch release experience

Education

Degree/HNC/HND or equivalent in scientific/engineering

Tools

ERP

LIMS

Quality management software

Job description

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

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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

If you have the following characteristics, it would be a plus:

• 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., 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

This job is with GSK, an inclusive employer and a member of myGwork - the largest global platform for the LGBTQ+ business community.

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., 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.