Clinical Quality Risk Management Lead

Novocure; Baar; Hybrid; CHF 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Travel up to 20%

Zusammenfassung

Novocure is seeking a Clinical Quality Risk Management Lead to drive and advance the QRM framework across clinical studies, suppliers, and critical processes. You will coordinate with global teams to identify, assess, mitigate, monitor, and communicate quality risks that may affect patient safety and data integrity, while ensuring inspection readiness and regulatory compliance.

You will guide the implementation and training of risk-based quality practices, support regulatory submissions, and

Qualifikationen

• Degree in Medicine, Pharmacy, Life Sciences, or other relevant scientific/technical discipline, or equivalent experience.
• Demonstrated expertise in Clinical Quality Assurance and Quality Risk Management and inspection readiness in regulated clinical research.
• Strong understanding of clinical trial processes, development, and quality oversight activities.

Aufgaben

• Lead and enhance the Clinical Quality Risk Management framework across regulatory requirements and best practices.
• Identify emerging quality and compliance risks from audits, inspections, CAPAs, protocol deviations, and quality data.
• Oversee a cross-functional team to ensure risks affecting patient safety, data integrity, and compliance are managed.
• Maintain a centralized Clinical Quality Risk Register for visibility of enterprise risks.
• Provide guidance on applying RBQM principles across studies and suppliers.
• Drive continuous improvement by translating risks and lessons learned into QMS enhancements and training.
• Support regulatory submissions, audits, and health authority inspections with a risk-based approach.
• Act as subject matter expert to promote a culture of quality and risk-based decision making.
• Maintain expertise in applicable regulations and standards to ensure ongoing compliance.

Kenntnisse

Stakeholder management

Analytical skills

Problem-solving

Communication

Interpersonal skills

Ausbildung

Bachelor's degree in Medicine, Pharmacy, Life Sciences or related field

Jobbeschreibung

About The Role

At Novocure, every role contributes to extending the lives of people living with cancer. As our new Clinical Quality Risk Management Lead, you’ll play a key part in this mission.

The Clinical Quality Risk Management Lead is responsible for leading and advancing the Clinical Quality Risk Management (QRM) framework, to strengthen clinical quality governance and support clinical program-level risk oversight. The role ensures that risk-based quality management principles are integrated across clinical studies, clinical suppliers, quality systems, and critical clinical processes throughout the clinical trial lifecycle.

As the subject matter expert for Quality Risk Management, the role partners with Global Clinical Operations, Global Clinical Development, Data Management, Biostatistics, Global Clinical Safety, Regulatory Affairs, Medical Affairs, and other key stakeholders to proactively identify, assess, mitigate, monitor, and communicate quality and compliance risks that may impact patient safety, data integrity, regulatory compliance, inspection readiness, or clinical project execution.

This role contributes to continuous improvement initiatives, inspection readiness programs, and regulatory submissions while fostering a culture of quality and risk-based decision-making across the organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead and continuously enhance the Clinical Quality Risk Management framework, ensuring alignment with regulatory requirements, industry best practices, and organizational objectives.
• Proactively identify emerging quality and compliance risks by analyzing trends from audits, inspections, CAPAs, protocol deviations, GCP non compliances, quality metrics and other relevant quality data sources,
• Establish, maintain and lead a cross-functional team to ensure significant risks impacting patient safety, data integrity, and regulatory compliance and inspection readiness. are identified, assessed, documented, assigned, monitored, periodically reviewed and escalated as appropriate.
• Establish and maintain a centralized Clinical Quality Risk Register to support the assessment, documentation, monitoring and visibility of enterprise clinical quality risks.
• Provide the oversight and guidance on the application of Quality Risk Management and Risk-Based Quality Management (RBQM) principles across clinical studies, quality systems, clinical suppliers and critical clinical processes.
• Support continuous improvement initiatives by ensuring that identified clinical quality risks and lessons learned are translated into enhancements to the Quality Management System (QMS), Support the study teams in the implementation, training, and adoption of these improvements across clinical studies and relevant functions and monitor their effectiveness in mitigating identified risks.
• Support global inspection readiness, regulatory submissions, audits, and health authority inspections through a proactive, risk-based approach.
• Act as the Clinical Quality Risk Management subject matter expert, providing consultation, training, and leadership to promote a culture of quality, compliance, and risk-based decision-making.
• Maintain expertise in applicable regulations, industry standards, and quality risk management practices to ensure ongoing compliance and organizational readiness.

QUALIFICATIONS/KNOWLEDGE:

• Degree in Medicine, Pharmacy, Life Sciences, or other relevant scientific/technical discipline, or equivalent experience.
• Significant experience in the medical device, biotechnology, or pharmaceutical industry, including direct involvement in the conduct, oversight, and quality management of clinical studies.
• Demonstrated expertise in Clinical Quality Assurance, Quality Risk Management, and inspection readiness within regulated clinical research environments.
• Strong experience applying Quality Risk Management principles and methodologies to proactively identify, assess, mitigate, monitor, and communicate quality and compliance risks across clinical programs and processes.
• Sound understanding of clinical trial processes, clinical development, study execution, and quality oversight activities.
• Strong knowledge of applicable regulations and standards, including ISO 14155, ICH-GCP, and relevant global regulatory requirements.
• Experience supporting regulatory inspections, audits, and health authority interactions.
• Demonstrated ability to lead and influence within complex cross-functional and matrix organizations.
• Strong stakeholder management skills, with the ability to build partnerships, drive alignment, and promote risk-based decision-making.
• Excellent analytical, problem-solving, communication, negotiation, and interpersonal skills.
• Highly organized, adaptable, and able to manage multiple priorities in a dynamic global environment.
• Strong integrity, professional judgment, and results-oriented mindset.
• Fluent in English; additional language skills, particularly German, are advantageous.
• Willingness to work in a global environment and travel up to 20% domestically and internationally.

NOVOFLEX

We offer a flexible, trust-based hybrid working model for most of our office-based roles. Employees are asked to be in the office an average of three days per week, with the flexibility to choose which days' work best for them. We understand that life is not always predictable, so if you need to adjust your schedule, such as leaving early or starting late occasionally, we trust you to balance your time in a way that works for both you and Novocure.

About Novocure

Novocure is a company with a powerful mission, to extend the lives of people living with some of the most aggressive forms of cancer. Here your work will have a direct impact on patients and those who care about them. Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together. Here, you'll connect, grow, and make a real difference. We're a company with the drive of a startup and the strength that comes with 25 years of success.

Novocure operates at a rare crossroad, where advanced medical technology converges with cutting-edge biotechnology. We are the only company to develop and commercialize Tumor Treating Fields (TTFields), a proprietary, groundbreaking therapy designed to disrupt cancer cell division. With us you will find a unique combination of laboratory research work alongside engineering development of advanced technologies. This fusion of disciplines positions us as true pioneers in oncology innovation, leading a new frontier in the treatment of aggressive cancers.

Our patient-forward values:

• innovation
• focus
• drive
• courage
• trust
• empathy