Head of Quality Assurance (QA)

Join Phagos, a pioneering biotechnology company focused on developing bacteriophage-based veterinary medicines. As the Head of Quality Assurance, you will be responsible for designing and implementing the Quality Management System (QMS) for our new GMP manufacturing facility. You will lead regulatory submissions, oversee facility qualification and quality operations, and build and lead the site QA team. This role requires a Master's degree or PharmD in a related field, a minimum of 8-10 years of experience in biotech or pharmaceutical QA, and deep expertise in EU biological/veterinary GMP guidelines.

• Concevoir, mettre en œuvre et maintenir le système de gestion de la qualité (QMS) du site, conforme aux directives GMP vétérinaires de l'UE.
• Diriger la préparation et la compilation du dossier technique pour la demande d'autorisation d'ouverture auprès de l'ANMV.
• Superviser la qualification des équipements, la validation des installations, la mise en service des salles blanches et la validation des processus.

• Master’s degree or PharmD in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related Life Sciences discipline.

• *QP qualification under Article 97 of Regulation (EU) 2019/6 is an advantage (though the QP role is structured separately)*.

• Minimum 8–10 years of experience in biotech or pharmaceutical QA, with hands-on experience in a **GMP manufacturing site**.

• Prior experience building or contributing to a greenfield site authorization (*Autorisation d’Ouverture*).

• Startup or scale-up biotech experience is strongly preferred.

• Deep expertise in EU biological/veterinary GMP guidelines (Eudralex Vol. 4, Regulation EU 2019/6, EU Pharmacopeia).

• Experience with live biological products (vaccines, cell therapy, or bacteriophages) and live biological CMC requirements.

• Proven track record in designing QMS documentation, VMFs, VMPs, and validation protocols.

• Direct experience handling ANMV or equivalent EU national authority inspections.

• **Leadership & Vision:** Demonstrated success in building, mentoring, and leading QA teams.

• **Pragmatic & Solution-Oriented:** Comfortable with ambiguity and enthusiastic about establishing framework models for novel, fast-moving biological products.

• **Languages:** **Fluent English** (essential for EMA dossiers and international communication); **French proficiency** is strongly preferred (for local ANMV interactions and on-site leadership).