Winter Co-op/R&D Quality and Risk Management

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

 

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together

Department Description

The R&D Quality and Risk Management (QuRE) department is responsible for ensuring quality, risk management, and operational excellence across all research and development activities. The team partners strategically with business units to build quality into processes early, proactively manage risks, and support inspection readiness. Key functions include Quality Assurance, Risk & Quality Management Systems, Functional and Process Quality, Therapeutic Area Quality, Third Party Quality, Auditing, Inspection & Intelligence, Governance & Risk, and Quality Services & Solutions.

The department’s objectives are to:

• Accelerate innovation through “Quality by Design”
• Administer robust audit and inspection programs
• Integrate risk management into business planning and performance
• Drive continuous improvement through data analytics and lessons learned
• Support due diligence, M&A, and regulatory compliance

QuRE provides dedicated support for functions and processes, manages quality strategies at the program/asset level, oversees vendor qualifications, and leads cross-functional issue management. The team fosters a culture of quality, compliance, and risk awareness to enable safe, effective, and innovative R&D outcomes.

Job Description

The R&D Quality and Risk Management Co-op will support the R&D QuRE (Quality, Risk, and Excellence) team in delivering quality assurance, risk management, and operational excellence across research and development functions. This role is designed for a motivated student seeking hands-on experience in pharmaceutical R&D quality and risk management.

Quality Business Partner Support

• Collaborate with functional and process quality teams to provide dedicated quality support for R&D functions and processes.
• Assist in developing and implementing fit-for-purpose quality strategies (e.g., Precision Medicine, Digital Health, AIML, Safety, Regulatory Affairs).
• Support process oversight, advice, and lessons learned initiatives.
• Participate in inspection readiness and preparedness programs.
• Contribute to due diligence activities and M&A support.

Quality Assurance

• Assist in administering audit programs focused on high-risk areas.
• Support the preparation, conduct, and reporting of GLP, GCP, and GVP audits (internal and external).
• Help coordinate pre-inspection visits and sponsor mock inspections.
• Participate in horizon scanning of inspection trends and industry benchmarking.

Risk & Quality Management System

• Support the integration and execution of R&D Quality Management Systems (QMS).
• Assist in risk assessments, issue management, and CAPA (Corrective and Preventive Actions) processes.
• Help gather and analyze risk data and insights to facilitate management reviews and continuous improvement.
• Participate in business operations support, including communication and engagement plans (e.g., newsletters, townhalls).

Quality Services & Solutions

• Contribute to the development and deployment of strategies for quality planning, KPI monitoring, and roadmap execution.
• Support knowledge management and collaboration tools.
• Assist in IT system validation, electronic data integrity, and readiness assessments.

Minimum Qualifications

• Pursuing a BS degree in Life Science, Business, Reg