JOB SUMMARY:

The Clinical Quality Assurance Manager is responsible for providing independent, risk-based quality oversight of clinical studies, programs, vendors, systems, and processes and supporting the integration of clinical activities into Novocure’s Quality Management System.

The role includes managing and developing Clinical Quality team members, partnering with internal and external stakeholders, and ensuring compliance with Novocure procedures, study plans, Good Clinical Practice, applicable regulations, and ISO 14155.

The position may also lead or conduct audits and support quality issue management, inspection readiness, and continuous improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide proactive, independent, and risk-based Clinical Quality oversight throughout the clinical study lifecycle.
• Manage, coach, and develop Clinical Quality team members and ensure appropriate resource allocation across assigned studies.
• Partner with Clinical Operations, Medical, Safety, Regulatory Affairs, Data Management, Biostatistics, and other functions to identify and manage risks affecting participant protection, data reliability, study integrity, and regulatory compliance.
• Provide Clinical Quality input into key study documents, risk assessments, quality plans, and inspection-readiness activities, as applicable.
• Lead or oversee the evaluation, escalation, and resolution of clinical quality issues, deviations, and potential serious non-compliance.
• Manage CAPAs and ensure that root causes, containment actions, corrective and preventive actions, and Evidence Checks are appropriate and completed within agreed timelines.
• Prepare and present study quality reviews, including significant risks, quality indicators, issues, CAPAs, audit observations, and action plans.
• Oversee the qualification and quality performance of CROs and other clinical vendors through governance meetings, quality agreements, audits, metrics, and issue management.
• Contribute to the development and execution of the risk-based Clinical Quality audit program and lead or conduct audits, as assigned.
• Support regulatory inspections and external audits, including readiness assessments, interview preparation, inspection hosting, response development, and follow-up activities.
• Support the development, implementation, maintenance, and continuous improvement of the Clinical Quality Management System.
• Contribute to the development and review of policies, SOPs, work instructions, templates, systems, and training materials relevant to clinical activities.
• Maintain current knowledge of applicable regulations, standards, guidance, and Novocure procedures.
• Promote a proactive quality culture and provide clear, practical, and risk-proportionate guidance to stakeholders.
• Promptly escalate significant quality and compliance risks to Clinical Quality leadership and the appropriate governance forums.

QUALIFICATIONS/KNOWLEDGE:

Qualifications and experience

• Bachelor’s degree or higher in life sciences, medicine, pharmacy, nursing, engineering, quality management, or another relevant scientific or technical discipline.
• Minimum of seven years of relevant experience in Clinical Quality Assurance, Clinical Operations, or another GCP-regulated clinical research function, including substantial quality responsibilities.
• Experience in the pharmaceutical, biotechnology, or medical device industry. Medical device clinical investigation experience is preferred.
• Demonstrated experience in clinical study oversight, vendor management, quality issue management, CAPAs, and inspection readiness.
• People-management
• Strong working knowledge of Good Clinical Practice, ISO 14155, the EU Medical Device Regulation, ICH-GCP, and applicable clinical research requirements.
• Knowledge of risk-based quality management, data integrity and computerized systems validation.
• Fluency in written and spoken English is required. German or another additional language is an advantage.
• Willingness to travel domestically and internationally, based on business needs, up to approximately 30%.

Knowledge

• Strong leadership, coaching, communication, and stakeholder-management skills.
• Sound judgment and the ability to make and communicate risk-based quality decisions.
• Strong analytical, critical-thinking, and problem-solving skills.
• Ability to influence cross-functional stakeholders while maintaining Clinical Quality independence and objectivity.
• Highly organized, detail-oriented, and able to manage multiple priorities in a changing international environment.
• Ability to work independently and escalate matters appropriately.
• High degree of integrity, accountability, discretion, and professional courage.
• Results-oriented and committed to participant protection, data reliability, compliance, and continuous improvement.