Directeur Assurance Qualité (Pharm. D.)

Description du poste et des missions

Background and purpose

Carthera, a French clinical-stage company focused on the co-development of an innovative ultrasound-based medical device combined with therapeutic agents to treat a wide range of brain diseases, is hiring a Director of Quality Assurance (Pharmacist) 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 trail 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 was recently granted the Orphan Drug Designation in Europe and in the United States.

Carthera is recruiting a Director of Quality Assurance to operate a pharmaceutical transition for its Quality and Regulatory Affairs department. The Quality Director will develop, implement, monitor, and oversee the company’s entire quality assurance function, supporting the preparation of the Marketing Authorization of a breakthrough medicinal product-medical device solution.

Mission of the position

In collaboration with different departments of Carthera, the Director of Quality Assurance will be responsible for developing, implementing, monitoring, and overseeing the company’s quality assurance function, GxP / ISO 13485 Quality Systems and Practices in alignment with the strategy and objectives of the company.

Main activities and tasks of the position

• Develop QA department organizational, resource planning, and continuous improvement strategy


• Lead the quality department and oversee the quality policy implementation and quality management system improvement


• Manage QA team members, recruitment, integration, training needs, goal setting, and performance management in accordance with the company’s HR policies


• Act as a senior management representative in meetings with investigators, pharmaceutical partners, and regulatory agencies


• Oversee the management, issuance and tracking of the company's Quality System and ensures it is appropriately documented and implemented


• Lead the quality system changes, new initiatives, and process improvement to support evolving regulations and international standards


• Design, implement and guarantee the operation of the Quality System in compliance with FDA, ICH, ISO 13485 and applicable Good Pharmaceutical Practices (GxPs)


• Manage the CAPA, change control, deviation, and risk assessment programs


• Secure relations with external pharmaceutical partners (manufacturers, distributors, subcontractors) by drawing up contracts and Quality Agreements


• Plan and conduct internal and external audits according to the established plans, needs and the criticality of the audits; provide overviews of audit findings for presentation to management as required


• Create an environment where continuous improvement is part of the teams’ activities. Implement and monitor performance indicators for the company

Hierarchical position

Reports directly to the CEO

Profil souhaité

• Doctorate in pharmacy, Registered pharmacist


• 10+ years' experience in Biotech/Pharmaceutical industry and in QA with extensive knowledge of Quality Management Systems, including at least 3 years in a management role


• Fluent in verbal and written English


• Intellectually curious, self-motivated, autonomous


• Proficient with Microsoft Office tools

Compétences requises

• Extensive GxP quality experience in drug-candidate development with proven experience with drugs in clinics


• Experience working with Contract Organizations, Service Providers, and other entities which provide GxP contracted services


• Advanced knowledge and understanding of GxP regulatory requirements and implementation (FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities)


• Experience with medical devices / ISO 13485 environment would be preferred

Lieu de la mission