GSK
Operational Quality Advisor
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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
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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.
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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.
How to apply
If this role feels like your next step, please apply and briefly tell us how your experience meets the responsibilities and qualifications above. If you need reasonable adjustments during the recruitment process, please tell us. We look forward to hearing from you.
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.
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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.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive
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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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