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About the Role

At the heart of global clinical development, quality is a discipline that shapes every decision. In this pivotal role, you will serve as a subject matter expert in risk-based quality management, guiding cross-functional study teams to embed quality principles from the earliest stages of clinical trial design through to completion. You will lead the implementation and continuous improvement of quality processes across the clinical development lifecycle, ensuring that critical data and processes are identified, risks are proactively managed, and trials are consistently inspection-ready.

Responsibilities

Lead the implementation and continuous improvement of quality processes across the clinical development lifecycle.
Define quality tolerance limits.
Maintain quality risk management plans.
Support risk-based monitoring strategies.
Co-lead preparation for regulatory authority inspections.
Lead the investigation of and response to quality issues, driving accountability and continuous improvement across assigned trials.
Oversee third-party quality performance.

Requirements

Hold a degree in medical science, life science, or a related field (a postgraduate qualification is preferred).
Bring at least eight years of hands-on experience spanning the full clinical development lifecycle, including trial design, start-up, conduct, analysis, and reporting.
Have deep expertise in clinical quality risk management, Quality by Design principles, risk-based monitoring, and Good Clinical Practice inspection readiness.
Possess a strong working knowledge of international regulatory requirements and harmonisation guidelines.
Have direct experience supporting or co-leading regulatory authority inspections.
Be confident maintaining inspection-readiness tools and quality risk management plans throughout the trial lifecycle.
Be experienced in working with contract research organisations and external vendors in an international, cross-functional matrix environment.
Bring strong analytical and project management capabilities.
Have a proven ability to identify critical-to-quality risks, define meaningful quality tolerance limits, and translate complex quality data into clear, actionable insights for diverse stakeholders.
Communicate with clarity and confidence.
Be skilled at influencing without authority.
Be able to explain complex regulatory and quality topics to both technical and non-technical audiences across all levels of an organisation.
Be proactive, accountable, and committed to continuous improvement.
Have the ability to work independently in a complex multinational environment while actively supporting and coaching colleagues.

Skills

Risk-based quality management
Clinical trial design
Quality by Design principles
Risk-based monitoring
Good Clinical Practice inspection readiness
International regulatory requirements
Harmonisation guidelines
Regulatory authority inspections
Quality risk management plans
Analytical capabilities
Project management capabilities
Stakeholder communication
Influencing without authority
Coaching colleagues

Location

UK
Poland

Work Type

Full-time

Experience Level

8+ years of experience

Education Level

Degree in medical science, life science, or related field
Postgraduate qualification preferred

Benefits

Opportunities for personal development
Career advancement opportunities

About the Company

Colleagues across the globe innovate with science and technology to enrich people’s lives in Healthcare, Life Science, and Electronics.
The company dreams big and is passionate about caring for its rich mix of people, customers, patients, and planet.
The Healthcare purpose is to help create, improve and prolong lives by developing medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.
Teams work together across 6 continents with passion and relentless curiosity to help patients at every stage of life.
The company offers a diverse, inclusive and flexible working culture.
The company is committed to creating access and opportunities for all to develop and grow at their own pace.
The company is dedicated to Sparking Discovery and Elevating Humanity.