Novocure is looking for a Clinical Quality Associate to join our Clinical Quality function. In this role, you will serve as a key Quality Assurance partner to Clinical Development, Clinical Operations, Clinical Safety, and Clinical Supply Chain teams. You will provide 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.
What You'll Do
- Serve as the Clinical Quality Assurance key contact for stakeholders involved in 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.
What We're Looking For
- 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.
Nice to Have
- 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.
Technical Stack
- eTMF
- TMF
- CTMS
Work Mode
This position operates on a hybrid work model.
Novocure is an equal opportunity employer.
