Clinical Quality Risk Management Lead

Novocure

Switzerland

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.