Preclinical Quality Partner Driving R&D Quality by Design

GSK; Stevenage, Cambridge; On-site; GBP 90,000 - 120,000; Full time

Job summary

GSK in Stevenage is temporarily based there, with relocation to Cambridge planned by early 2029. This Quality Business Partner role provides strategic quality guidance for R&D, embedding Quality by Design and risk minimisation across assigned areas.

You will partner with R&D pre-clinical and data analytics to implement quality strategies, support CAPA, due diligence and cross-functional QMS activities, and foster a culture of quality across GSK and its partners.

Qualifications

• Bachelor's degree or equivalent in scientific or quality-related field, or equivalent combination of education, training and experience.
• Experience in drug development, regulatory compliance or quality management.
• Expert knowledge of non-clinical research practices, GLP/GCP or Animal Welfare regulatory requirements.
• Demonstrated experience of diverse stakeholder management with the ability to influence.
• Broad working knowledge and expertise in principles and concepts of quality by design and risk management.
• Expert working knowledge in continuous improvement with a background in the appropriate tools.

Responsibilities

• Serves as the Quality Business Partner for Research across R&D.
• Defines the activities that need to be conducted to deliver quality strategies for R&D Research.
• Collaborates with the Risk and Issue Management team within R&D Quality and Risk Management and the Research organisation to deliver quality activities that drive quality by design.
• Shares key learnings to drive simplification and replicate best practices to drive quality into the business.
• Works closely with business teams to provide expert quality information and support continuous improvement.
• Evaluates, and/or reviews procedures and other activities in support of an integrated, cross functional QMS.
• Fosters a commitment to quality in individuals and a culture of quality across GSK and GSK Third Parties. Facilitates effective communication and knowledge sharing across teams to promote a culture of quality.
• Supports due diligence and Merger & Acquisition activities.
• Works with R&D Data Analytics to define KPI, KQI and metrics needs for R&D Quality and Risk Management and stakeholders.
• Ensures rapid communication of quality issues and risks, including potential misconduct, to appropriate leaders and colleagues.
• Supports issues identification, reporting, root cause analysis and CAPA development.
• Supports the investigations of potential serious and critical issues.
• Participates in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT.

Skills

Quality by Design

Risk management

Stakeholder management

Continuous improvement

Quality systems

Communication

Education

Bachelor's degree in science or quality-related field

Tools

Quality management tools

Job description

GSK in Stevenage is temporarily based there, with relocation to Cambridge planned by early 2029. This Quality Business Partner role provides strategic quality guidance for R&D, embedding Quality by Design and risk minimisation across assigned areas.

You will partner with R&D pre-clinical and data analytics to implement quality strategies, support CAPA, due diligence and cross-functional QMS activities, and foster a culture of quality across GSK and its partners.