Associate Director, Clinical Quality Management Lead

Merck Group; United Kingdom; Presencial; GBP 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Descripción de la vacante

Merck Group is seeking an experienced life sciences professional to lead risk-based quality management across the clinical development lifecycle. You will embed quality principles from study design to completion while ensuring trials remain inspection-ready and compliant with international regulations.

In this role, you will define quality tolerance limits, maintain risk plans, and co-lead regulatory inspections.

Formación

• Degree in medical science, life science, or a related field (postgraduate preferred).
• Eight years of hands-on experience across the full clinical development lifecycle.
• Deep expertise in clinical quality risk management and Quality by Design.
• Strong knowledge of regulatory requirements and GCP inspection readiness.
• Experience supporting or co-leading regulatory authority inspections.
• Experience working with CROs and external vendors in international settings.
• Analytical and project management capabilities with ability to translate data into insights.
• Excellent communication and ability to influence across levels of an organisation.
• Proactive, accountable, and able to work independently in a multinational environment.

Responsabilidades

• Lead as a subject matter expert in risk-based quality management across the clinical development lifecycle.
• Embed quality principles from trial design through to completion and ensure inspection readiness.
• Define quality tolerance limits and maintain quality risk management plans.
• Support risk-based monitoring strategies and co-lead preparation for regulatory inspections.
• Investigate quality issues and drive continuous improvement across trials.

Descripción del empleo

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role

At the heart of global clinical development, quality is not a checkpoint, it 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. Working closely with contract research organisations, vendors, and international study teams, you will define quality tolerance limits, maintain quality risk management plans, support risk-based monitoring strategies, and co-lead preparation for regulatory authority inspections. You will also lead the investigation of and response to quality issues, driving accountability and continuous improvement across assigned trials.

The role could be based either in the UK or in Poland.

Who You Are

• You hold a degree in medical science, life science, or a related field (a postgraduate qualification is preferred), and bring at least eight years of hands-on experience spanning the full clinical development lifecycle, including trial design, start-up, conduct, analysis, and reporting.
• You have deep expertise in clinical quality risk management, Quality by Design principles, risk-based monitoring, and Good Clinical Practice inspection readiness, with a strong working knowledge of international regulatory requirements and harmonisation guidelines.
• You have direct experience supporting or co-leading regulatory authority inspections and are confident maintaining inspection-readiness tools and quality risk management plans throughout the trial lifecycle.
• You are experienced in working with contract research organisations and external vendors in an international, cross-functional matrix environment, and can effectively oversee third-party quality performance.
• You bring strong analytical and project management capabilities, with 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.
• You communicate with clarity and confidence, are skilled at influencing without authority, and can explain complex regulatory and quality topics to both technical and non-technical audiences across all levels of an organisation.
• You are proactive, accountable, and committed to continuous improvement, with the ability to work independently in a complex multinational environment while actively supporting and coaching colleagues.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!