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Chargé.e d’Assurance Qualité Clinique – F/H

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Présentation société

Carthera® est une société de medtech en phase d’évaluation clinique qui développe des dispositifs médicaux innovants basés sur l’utilisation des ultrasons pour traiter un large éventail de pathologies cérébrales graves

Background and purpose 

Carthera, a French clinical-stage medtech company focused on developing innovative ultrasound-based medical devices to treat a wide range of brain diseases, is hiring a Quality Assurance Manager to be based in Lyon, France.

Carthera has developed the SonoCloud®, an innovative medical device that emits ultrasound to temporarily increase the permeability of blood vessels in the brain. SonoCloud® is an intracranial implant listed as a Breakthrough Device by the FDA. It disrupts the blood-brain barrier (BBB) at time of administration of therapeutic agents such as chemotherapy or immunotherapy. Several minutes of low-intensity pulsed ultrasound (LIPU) is sufficient to open the BBB for several hours, thus increasing the concentration of therapeutic molecules in the brain, and potentially their effectiveness.

Carthera is currently advancing this technology for the treatment of brain cancer and neurodegenerative diseases. Its most advanced trial is a phase 3 study evaluating the efficacy of carboplatin in combination with BBB opening with the SonoCloud® for the treatment of recurrent glioblastoma. This medicinal product containing carboplatin recently gained the Orphan Drug Designation in Europe and in the United States.

Carthera is recruiting a Quality Assurance Manager to strengthen the clinical team's expertise and to contribute to the development of the SonoCloud® solution.

Mission of the position

The Quality Assurance Manager will ensure that clinical trials comply with the quality standards, good clinical practices and legal, ethical and regulatory requirements. He/She will provide support to operational teams and ensure trials quality by setting up and maintaining an appropriate documentation.

Main activities and tasks of the position

- Contribute to the issuance and tracking of the Clinical Affairs' quality system and ensure it is appropriately documented and implemented

- Participate in the implementation and monitoring of risk management plans for clinical trials

- Evaluate non-conformities/deviations/complaints, elaborate and monitor the implementation of preventive or corrective actions plans

- Organize, plan and monitor internal and external quality audits (including via selected service providers)

- Ensure compliance with audit schedules

- Carry out quality controls of the clinical documentation /self-inspection

- Lead the quality system changes and process improvement to support evolving regulations, new initiative and development of the company

- Maintain up-to-date knowledge of FDA, EU, national regulations and other applicable standards

- Raise awareness of Carthera’ s teams by organizing quality training program per the GxP requirements

- Perform other GCP duties and any cross-functional activities with R&D or QARA departments as assigned

Hierarchical position

The Quality Assurance Manager reports directly to the Chief Clinical Officer. He/She will be the key contact between the Clinical Affairs Department and the QARA department.

Carthera offers

• The option to partially work from home
• The opportunity to participate in the development of a disruptive technology in a fast-growing French/American company and to be part of a dynamic, friendly, and supportive team
• Competitive salary and benefits

Descriptif du profil

Profile

• Proven experience in Biotech/Pharmaceutical industry in clinics and QA with extensive knowledge of GCP Quality Management Systems
• Ideally, previous experience in medical device environment and/or medicines in international organization
• Fluent in verbal and written English
• Able of pragmatic approach to support the operational team in its day-to-day activities
• Intellectually curious, self-motivated, autonomous
• Proficient with Microsoft Office tools

Postuler

Carole Desseaux
carole.desseaux@carthera.eu