Chargement en cours

Quality Manager (Lab Ops / GMP)

SURESNES, 92
il y a 3 jours

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 Offer

  • International 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, and a healthy work‑life balance culture.

If you’re excited by science with real‑world impact and want to help rewrite the future of animal health—we’d love to chat.

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Entreprise
Phagos
Plateforme de publication
WHATJOBS
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