Site Quality Head & Qualified Person M - F H/F - Talented International

Talented International est un cabinet de recrutement spécialisé dans les profils en fonction support et Retail, ainsi que les domaines techniques pointus.Nos lignes de métiers sont : - Comptabilité / Finance- Paie / RH- Logistique / Supply-Chain- Retail - Ingénierie / TechnologiesNous accompagnons des entreprises i sur des recrutements ciblés, en France et à l'international, avec une approche terrain, pragmatique et orientée qualité. Notre objectif est de créer des rencontres durables entre des projets techniques exigeants et des profils experts.
We are partnering with a specialized biologics testing and viral safety CRO, part of a top-tier global life sciences organization. Known for its cutting-edge proprietary NGS (Next Generation Sequencing) platforms, the company provides expert end-to-end quality control solutions for innovative biotech companies worldwide. We are looking for a Site Head of Quality & Regulatory Affairs, who will also hold the concurrent Pharmacien Responsable (PR) / Qualified Person (QP) mandate. This is a rare opportunity to step into a leadership role with real scope: full site quality ownership, regulatory affairs accountability, and the PR mandate all in one position. What You'll Do : Site Quality LeadershipLead, manage, and develop the site quality organization with full people management accountability.Own and continuously improve the site QMS in compliance with EU GMP, 21 CFR Part 11, ANSM requirements, and global standards.Lead site readiness for regulatory inspections and client audits, acting as the primary site quality representative.Pharmacien Responsable / Qualified Person (QP)Fulfill all legal and regulatory obligations of the Pharmacien Responsable as defined under Article R5124-36 of the French Code de la Santé Publique.Serve as the site's Qualified Person (QP) for GMP activities; certify batches in accordance with applicable regulations and marketing authorizations.Hold and maintain the site's MOT authorization.Serve as the primary point of contact with ANSM and other competent health authorities.Designate and oversee the interim QP to ensure continuous QP coverage.Regulatory AffairsDefine and implement the site's regulatory strategy in alignment with R&D objectives.Manage lifecycle maintenance of regulatory dossiers (BLA, DMF, SMF, BMF, IND, IMPD).Respond to regulatory authority requests and maintain active legislative monitoring.

Mandatory Prerequisite: European pharmacy diploma (or recognized equivalent) and eligibility for registration in Section B of the Ordre des Pharmaciens (CNOP).Experience: 5+ years in QA/RA within pharma/biotech, with at least 3 years in a site quality leadership capacity.PR Experience: Minimum 5 years as a Delegated or Deputy Pharmacist; minimum 6 months as a Quality Control Manager (or equivalent).Technical Skills: Deep expertise in EU GMP, ANSM regulations, and international frameworks (FDA, EMA, ICH). Experience in biologics, viral safety, cell/gene therapy, or a CRO/CDMO environment is strongly preferred.Languages: Fluent in both English and French (written and verbal).Leadership: Proven people management skills with the ability to communicate effectively with regulatory authorities, clients, and global senior leadership.