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EXExpanscience logo

Expanscience

FRA-PLD, France

RESPONSABLE AQ EXPLOITANT & DISTRIBUTION INTERNATIONALE.

Each person's potential contributes to success for all! We're Hiring! Job Description : Au sein de la Direction Qualité Globale, vous jouerez un rôle clé dans le pilotage et la conformité du Système Qualité Exploitant ainsi que dans la supervision des activités de distribution pharmaceutique en France et à l’international. En véritable garant.e de la conformité réglementaire et opérationnelle, vous aurez pour rôle de : - Piloter le Système Qualité du site exploitant (Revue de Direction, Comités Qualité Exploitant et Distribution Internationale, documentation qualité, inspections, audits, formation, déviations, CAPA, réclamations...) - S’assurer de la conformité de la distribution des produits en relation avec les distributeurs/ dépositaire et transporteurs utilisés (suivi des lots) - Participer aux projets touchant le périmètre concerné - Assurer la veille réglementaire dans votre périmètre - Superviser l’activité d’information promotionnelle des dispositif médicaux - Gérer le Système Qualité de la Distribution Internationale (exigences qualité pour les filiales et distributeurs internationaux, cahiers des charges, audits, sérialisation, anomalies, réclamations ... Profile Description : • Pharmacien inscriptible à la section B de l’Ordre des Pharmaciens, vous avez au moins 5 ans d'expérience en assurance qualité sur site exploitant et en distribution. Vous avez de très bonnes connaissances des référentiels : BPF, BPD, BPPV, réglementation pharmaceutique applicable à un établissement pharmaceutique Exploitant et charte de l’information promotionnelle des dispositifs médicaux. La connaissance de la réglementation MDR 2017/745 et de la norme ISO 13485 serait un plus. Vous maîtrisez les requis liés au système de management qualité Exploitant, les techniques d'audit, savez gérer des projets en mode transverse. Vous êtes capable de travailler et rédiger en anglais. What differentiates us at Expanscience (non-exhaustive list!) A care policy and improved occupational health (100% of managers trained in psychosocial risks by 2025) An ambitious talent and skills strategy (5.78% of the payroll in France allocated to training by 2023) Disruptive parenting support (gradual return to 80% of normal working hours for the first 2 months after maternity or paternity leave, with full pay), a fight against dropping out (individual coaching before, during and after maternity leave) and for professional equality (score of 93/100 on the Gender Equality Index in 2024) Support for vulnerabilities and inclusion of the most fragile (menstrual leave in case of disabling dysmenorrhea) A balance of life and preserved collective efficacy (disruptive teleworking agreement with 1 common base of 4 days of min. presence per month concentrated around key moments of the company) Employees as stakeholders in a more inclusive and supportive company (100% of employees can dedicate part of their working time to a community project) And also: Active sponsorship since 1982: the Mustela Foundation, under the aegis of the Fondation de France, which supports child development and parenthood throughout the world. Active sponsorship since 1982: the Mustela Foundation, under the aegis of the Fondation de France, which supports child development and parenthood throughout the world. You don’t give your all for over seventy years without a good reason… At Expanscience, we are a mission-driven company, and our purpose is to help individuals shape their well-being, from the youngest to the oldest. It’s what inspires our 1,300 employees to move forward, carry out research and innovate, every single day! Independence is our lifeblood. We’re a French company that is 100% family-owned, with products in over 90 countries. Our positive impact on society and the environment has been recognized by the B Corp label, and we commit to being a company that’s better for the world. Better for our employees, too, through the promise we make to develop the potential of each and every one of them! Our mission applies first and foremost to our teams. On a day-to-day basis, this means strengthening quality of life at work and professional equality, supporting those in vulnerable situations and promoting the inclusion of the most fragile members of society, proposing an ambitious talent and skills strategy and promoting work-life balance and collective efficacy. This requires ambitious measures that address the major societal challenges facing 21st-century companies. And it is bearing fruit: we are proud to have been certified as a Great Place to Work in 100% of our subsidiaries for the second consecutive year!
Pay
Not stated
Where
FRA-PLD, France
Work
Not stated
Type
Not stated
Posted
23 Jun, 2026
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