Clinical Quality Risk Lead - RBQM & Compliance Excellence

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

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