Quality Validation and CSV Senior Specialist

You will lead and deliver Quality Assurance, New Product Introduction (NPI), Validation and Computerised Systems Validation (CSV) activities across projects and operations, working closely with project teams, engineering, IT and manufacturing to ensure systems, processes and products are implemented and maintained in a compliant and effective manner. You will plan, execute and document risk-based quality and validation activities, provide practical problem-solving expertise, and support teams to achieve project and operational objectives on time.

We value clear communicators who make evidence-based decisions, foster collaboration and drive continuous improvement. This role offers significant opportunities for professional growth, the chance to make a measurable impact on patient supply, and the opportunity to help unite science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career.

These responsibilities include some of the following:

• Plan, lead and execute validation activities for processes, facilities, equipment and simple computerised systems.
• Provide quality oversight for new product introduction, technical transfers and batch documentation.
• Prepare and maintain validation protocols, test scripts, final reports and supporting evidence.
• Make timely, documented, risk-based quality decisions and clearly communicate rationale to stakeholders.
• Support internal and external inspections, prepare evidence and close agreed actions.
• Drive improvements to validation processes, templates and tools to increase efficiency and compliance.

Degree in a scientific, technical or engineering discipline, or equivalent relevant experience.

• Practical experience in validation or quality assurance in a regulated environment.
• Experience in computerised system validation or lifecycle activities for IT/automation systems.
• Working knowledge of good manufacturing practice (GMP) and quality management systems.
• Experience producing and reviewing validation and batch release documentation.
• Clear communication skills and ability to work effectively with cross‑functional teams.

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

• Advanced degree in science, engineering or a related technical field.
• Experience applying GAMP principles and data integrity requirements.
• Proven experience supporting regulatory inspections and interactions.
• Track record delivering validation for MES, automation or laboratory systems.
• Strong risk assessment skills and experience documenting risk-based decisions.
• Experience driving continuous improvement and validation tooling.

This role is a full time onsite role at Barnard Castle in the United Kingdom. On‑site presence will be required for inspections, validations and technical transfer activities.

We look for people who are curious, collaborative and accountable. We welcome different perspectives and aim to create an environment where everyone belongs. You will be supported to develop your skills and grow your career while helping deliver high quality products to patients.

Data Integrity, Detail‑Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Problem Solving, Project Management, Quality Assurance (QA), Risk Awareness, Technical Writing, Validation Processes

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…