Quality Consultant - Exploitant
Famille de fonction : Assurance qualitéRH@azurbio-pharma.com
Description du poste et des missions
About AzurBio Group
AzurBio Group is a fast-growing company offering strategic advice, tailored services, and innovative solutions to companies in the life sciences sector. We support our clients throughout the lifecycle of their healthcare products, with a particular focus on European regulatory compliance, especially in the areas of rare diseases and innovative therapies.
As part of our continued growth and organizational development, we are seeking a Quality Consultant– Exploitant (M/F) to join our team and ensure technical excellence in quality management, supporting compliance and operational excellence.
Position overview
As Quality Consultant – Exploitant, you will ensure compliance, quality oversight, and operational excellence across our Exploitant activities in France. You will also support product launches and maintain constructive interactions with health authorities.
Working closely with internal teams and clients, you will provide expert guidance on quality matters, drive continuous improvement, and ensure adherence to the highest compliance standards.
This role requires strong technical expertise, autonomy, and adaptability, as well as the ability to represent AzurBio and its clients with professionalism and integrity.
Key Responsibilities
- Provide strategic quality advice for the launch and lifecycle management of medicinal products in France.
- Support the set-up, maintenance, and continuous improvement of Exploitant QMS, including SOPs, audits, quality agreements, and third-party oversight.
- Ensure compliance with the Promotional Information Charter
- Conduct and coordinate audits on Exploitant processes, ensuring corrective/preventive actions are implemented.
- Support the preparation and execution of regulatory local launch activities (France/EU)
- Contribute to the preparation and submission of dossiers for Exploitant authorization.
- Interact with Health Authorities (ANSM and others) on quality-related matters
Why Join Us?
- Be part of a fast-growing company making a real impact on patients’ access to innovative medicines.
- Work in a dynamic, multicultural team environment with direct exposure to clients and health authorities.
- Competitive salary package and flexible working arrangements (hours and hybrid).
📍 Location: Paris 8th arrondissement , Sophia Antipolis (France) or remotely
🕒 Type: Full-time position
Interested? Please send your CV in English to RH@azurbio-pharma.com
Profil souhaité
- 5+ years of experience in quality management in the pharmaceutical/biotech industry, consultancy, or health authorities.
- In-depth knowledge of European and French quality regulations, particularly the Exploitant framework.
- Hands-on experience with Exploitant QMS, SOP writing/review, audits, and quality agreements.
- Familiarity with launch preparation and early access program quality requirements.
- Degree in Life Sciences or equivalent qualification.
- Strong interpersonal and communication skills, able to represent clients and AzurBio with health authorities.
- Proactive, solution-oriented, and skilled at managing multiple projects in a multicultural environment.
- Full professional proficiency in English and French.
