Head of Quality Assurance (QA)

Phagos; Arrondissement d'Évry; Sur place; EUR 150 000 - 210 000; Plein temps

Résumé du poste

Phagos recherche Head of Quality Assurance pour concevoir et déployer le QMS du nouveau site de fabrication, en conformité EU GMP et ANMV.

Vous dirigerez la préparation des dossiers d'autorisation, superviserez les validations IQ/OQ/PQ, et assurerez les inspections EMA/ANMV tout en bâtissant une équipe QA performante.

Anglais courant requis; poste basé à Suresnes, interactions avec R&D, production et regulatory.

Qualifications

• Master ou Doctorat ou diplôme équivalent en pharmacie ou sciences de la vie.
• Anglais courant essential pour les dossiers EMA.
• Expérience 8–10 ans en QA pharmaceutique/biotech sur site GMP.

Responsabilités

• Concevoir, implémenter et maintenir le QMS du site.
• Conduire l'autorisation ANMV et les dépôts VMF/MAA.
• Superviser les validations IQ/OQ/PQ et la qualification des installations.
• Coordonner les inspections ANMV et EMA et les audits simulés.
• Recruter et diriger l'équipe QA et instaurer une culture qualité.

Connaissances

Leadership

Anglais courant

Gestion de projet

Formation

Master ou PharmD en pharmacie/sciences

Outils

QMS platform

Gestion documents

Description du poste

• Team Building & Leadership

Descriptif du poste

As our Head of Quality Assurance, you will play a mission-critical role in bridging groundbreaking biological innovation with rigorous EU GMP compliance. Reporting directly to the Chief Operating Officer (COO), you will design, implement, and build the QA function for Phagos’s brand-new GMP manufacturing facility.

Your primary mission is to build our Quality Management System (QMS) from scratch, lead our site authorization (Autorisation d’Ouverture) with the French ANMV, support EMA centralized filings, and ensure our novel bacteriophage-based veterinary medicines meet the gold standard of quality.

Main Responsibilities

1 Greenfield project QMS Design & Implementation

• Build from Scratch: Design, implement, and maintain the site-wide QMS compliant with EU veterinary GMP guidelines, Regulation (EU) 2019/6, and Eudralex Volume 4.
• Documentation Architecture: Establish robust quality systems, policies, SOPs, batch record templates, and document control workflows.
• Digital Tools & Budget: Manage and optimize the QMS platform, document management tools, and QA budget for the new site.
• Regulatory Submissions & Site Licensing
• ANMV Site Authorization: Lead the preparation and technical dossier compilation for the ANMV Autorisation d’Ouverture application.
• Veterinary Master File (VMF): Draft and maintain the site VMF ahead of equipment qualification and production setup.
• EMA Centralized MAA: Oversee Module 3 (Quality/CMC) sections for EMA centralized Marketing Authorization Applications.
• Regulatory Authority Interface: Act as the primary point-of-contact for ANMV and EMA inspections and mock audits.
• Facility Qualification & Quality Operations
• Validation Oversight: Oversee equipment qualification (IQ/OQ/PQ), facility validation, cleanroom commissioning, and process validation.
• Batch Release Supervision: Coordinate with the Qualified Person (QP) and QC Manager to ensure defensible, compliant batch release processes.
• Quality Systems: Direct deviation management, CAPA, change control, OOS investigations, and pharmacovigilance processes.
• Team Building & Leadership
• Build & Lead: Recruit, structure, and direct the site QA team.
• Quality Culture: Champion a proactive, solution-oriented quality mindset across R&D, production, regulatory affairs, and management.

Profil recherché

• 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).

Déroulement des entretiens

Step #1 Screening call with Marine, our COO & Paula, our Regulatory Affairs Manager.

Step #2 Technical test, with our EU CMC external consultant.

Step #3 Chat with our Co-Founders

Team fit : Last but not least, you will meet 5 members of Phagos, randomly picked for a Team fit discussion in English. When possible, this meeting will be held in our office in Suresnes.

Qui sont-ils ?

Phagos is on a mission to create a cleaner, more sustainable future by using bacteria’s natural predator, the bacteriophage, to win the fight against antibiotic resistance and cure infectious diseases. We use breakthrough technologies in both the wet lab and dry lab to generate customized treatments for pathogenic diseases at an unprecedented speed.