Head of Quality Assurance (QA)

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.

2 . 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.

3 . 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.

4 . 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.

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).