Quality Manager (Lab Ops / GMP)

Phagos

Suresnes

Sur place

EUR 90 000 - 120 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Free breakfast
Sports activities
Healthy work-life balance culture

Résumé du poste

Phagos seeks an inaugural Quality Manager to bridge rapid innovation with strict regulatory compliance. You will design and implement a comprehensive QMS to support increased production and ensure our new veterinary lab setup meets global standards.

Key responsibilities include leading internal audits, supplier qualification, and developing training on documentation and quality processes, with a focus on GMP compliance and global submissions. English fluency is required.

Qualifications

  • Bachelors or equivalent in a life science field.
  • Experience in regulated biotech/pharma/veterinary environments preferred.
  • Proven familiarity with GMP and regulatory expectations.

Responsabilités

  • Design, implement and maintain a QMS compliant with biotech/pharma guidelines.
  • Lead internal audit programs ensuring ongoing readiness across operations.
  • Oversee supplier qualification and auditing to maintain supply chain integrity.
  • Develop and deliver training on documentation standards and quality procedures.

Connaissances

Quality management
Regulatory compliance
QA leadership
Documentation management
GMP guidelines

Formation

Degree in Pharmacy/Biology/Biotechnology

Outils

QMS software

Description du poste

As our first dedicated Quality Manager, you will bridge the gap between high-speed innovation and rigorous regulatory compliance. Your mission is to design and implement a Quality Management System (QMS) that supports our increased production needs and ensures our new lab setup meets the gold standard for global veterinary medicine.

Main Responsibilities

Quality Management System (QMS) Design

  • Build from Scratch: Design, implement, and maintain a robust QMS compliant with applicable biotech and pharmaceutical guidelines.

  • Audit Leadership: Manage the internal audit program across all operational areas to ensure constant readiness.

  • Supply Chain Integrity: Oversee the qualification and auditing of all suppliers and subcontractors.

  • Knowledge Culture: Design and deliver training programs on documentation standards and quality procedures for the whole team.

GMP & Regulatory Support

  • Lab Setup: Lead all quality aspects of the incoming GMP lab setup, including site qualification, equipment validation, and cleanroom procedures.

  • Global Submissions: Act as a key pillar in the preparation of regulatory dossiers from a quality and GMP compliance perspective.

  • Release Authority: Ensure batch release procedures are defensible, rigorous, and in place for all products released to the field.

Monitoring & Continuous Improvement

  • Incident Response: Lead post-incident quality reviews following field deviations or high-mortality cases to ensure we never stop learning.

  • Early Integration: Participate in new product and process development, acting as a proactive voice to raise quality issues during the design phase rather than after.

What We’re Looking For:Education: Degree in Pharmacy, Biology, Biotechnology, or a related life science discipline.Experience: Minimum 3-4 years in a quality role within a regulated biotech, pharma, or veterinary medicine environment.Technical Skills:Solid working knowledge of GMP guidelines.Familiarity with veterinary medicinal product regulations is a massive plus.Proficiency in designing and managing QMS software and documentation.Soft Skills: Comfortable with ambiguity, proactive in high-pressure situations, and able to translate complex regulations into clear team actions.Languages: Fluent in English.

What We OfferInternational Culture: Work with a global, diverse team driven by a shared vision of impactful biotechnology.Impactful Work: Lead processes that contribute directly to innovative biotechnologies.Growth & Learning: Gain valuable technical experience in a fast-paced environment.

Well-being Perks:

  • Free breakfast
  • Sports activities
  • A healthy work-life balance culture
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