Operational Quality Advisor

GSK

Scotland

Hybride

GBP 52 000 - 78 000

Plein temps

Il y a 3 jours
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Résumé du poste

GSK seeks an experienced Operational Quality professional to support and lead activities at the Irvine site in the United Kingdom. You will collaborate with site teams, regional quality colleagues and cross-functional partners to ensure the Quality Management System is applied effectively and drives improvements.

The role offers visible impact, learning opportunities and career growth within a global biopharma leader focused on vaccines and medicines; regular on-site presence with travel between

Qualifications

  • Must have degree or higher in a scientific/engineering field or equivalent practical experience.
  • At least 3–5 years’ experience in manufacturing quality in a regulated environment.
  • Solid knowledge of Good Manufacturing Practice or equivalent standards.

Responsabilités

  • 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 GMP compliance.
  • Drive quality improvement projects to simplify processes and raise right-first-time performance.
  • Coach site teams, manage escalations of significant quality risks and ensure consistent QMS application.

Connaissances

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

Formation

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

Outils

ERP systems
Laboratory Information Systems (LIS)
Quality Management Software

Description du poste

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

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