(Junior) Clinical Quality Associate

(Junior) Clinical Quality Associate

Novocure

Baar, Switzerland

This role sits within the Clinical Quality function and serves as a key Quality Assurance partner to Clinical Development, Clinical Operations, Clinical Safety, and Clinical Supply Chain teams. The (Junior) Clinical Quality Associate provides quality oversight across the full lifecycle of clinical studies, ensuring activities are planned, executed, and documented in compliance with GCP, regulatory requirements, and Novocure’s Quality Management System.

In this role, you will represent Clinical Quality Assurance with confidence and independence, providing hands-on guidance, driving issue resolution, and supporting inspection readiness. Your work will directly contribute to the quality, reliability, and credibility of Novocure’s clinical studies, supporting patient safety and regulatory success.

WHAT YOU’LL DO

In this role, you will be responsible for the following activities:

• Serve as the Clinical Quality Assurance key contact for stakeholders involved in the conduct of clinical studies, providing guidance across Clinical Development, Clinical Operations, Clinical Safety, and Clinical Supply Chain;
• Provide expert GCP guidance and ensure alignment with applicable regulations, guidelines, and industry standards;
• Support and manage inspection-readiness and inspection-preparation activities, ensuring timely reporting and effective communication;
• Manage quality compliance issues, including deviations, CAPAs, quality events, and complaints, ensuring consistent documentation, follow-up, and resolution;
• Contribute to the development, review, and continuous improvement of Quality Assurance procedures, including SOPs and Work Instructions;
• Support the integration of clinical study processes into Novocure’s Quality Management System;
• Deliver training to internal stakeholders on applicable regulations, ICH GCP guidelines, and internal quality procedures;
• Support cross-functional quality initiatives and strategic quality action plans, ensuring milestones and deliverables are met;
• Stay current with applicable global regulations and standards, including EU Clinical Trial Regulation, Medical Device Regulation, FDA 21 CFR, ICH GCP, ISO standards, and relevant regulatory guidance.

ABOUT YOU

Minimum Requirements:

• Scientific degree in a medical, pharmaceutical, biotechnological, or related field;
• At least 2 years of experience in Quality Assurance within a pharmaceutical or medical device regulated environment;
• Experience supporting clinical studies and working in accordance with ICH-GCP guidelines;
• Strong communication skills in English, both written and verbal;
• Ability to work independently with a high level of ownership and accountability.

These additional qualifications are preferred:

• Understanding of medical device environment and knowledge of applicable standards such as EN ISO 14155;
• Experience working with CROs and outsourced clinical activities;
• Previous experience with regulatory inspections;
• Familiarity with clinical systems and tools such as eTMF, TMF, and CTMS;
• Strong organizational skills with the ability to follow up on complex quality issues over extended timelines;
• Ability to bring cross-functional stakeholders together to drive resolution of quality topics.