Quality Assurance Manager

Metric Bio; Lille; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

Une entreprise dynamique recherche un Quality Assurance Manager pour son site en France. Le candidat idéal aura une expérience significative en assurance qualité, avec des compétences en gestion d'équipe et une solide compréhension des normes GMP. Ce rôle implique la gestion des audits, la conformité réglementaire et l'amélioration continue des processus de fabrication.

Qualifications

• 5 ans d'expérience en assurance qualité.
• Expérience en gestion d'équipe.
• Bonne compréhension des API et du remplissage/finissage stérile.

Responsabilités

• Gérer les inspections réglementaires et la conformité qualité des produits.
• Examiner les dossiers de lots et approuver la libération des produits finis.
• Gérer les plaintes clients et coordonner avec les équipes transversales.

Connaissances

Rigueur

Organisation

Esprit analytique

Communication

Leadership

Formation

Diplôme en Science / Ingénierie (BAC +5) ou formation de Pharmacien

Description du poste

Metric Bio are partnered with a leading CDMO with facilities across 3 continents, as they search for a Quality Assurance Manager , to make an impact on their site in South-West France.

• Note : This role is on-site in South-West France (relocation support is available).
• Full-Time

Join a dynamic, GMP-regulated environment as a Quality Assurance Manager , where you'll lead key quality systems, ensure regulatory compliance, and drive continuous improvement across manufacturing and operations.

Key Responsibilities :

• Manage regulatory inspections, internal / external audits, and product quality compliance.
• Review batch records and approve finished product release and, when necessary, product recall.
• Investigate deviations and manage CAPAs to ensure timely and effective resolution.
• Address and resolve customer complaints in coordination with cross-functional teams.
• Oversee quality documentation, supplier qualification, and validation activities.
• Monitor site KPIs and implement improvements; manage departmental budget.
• Ensure compliance with EHS and Quality requirements as per internal standards.
• Serve as the point of contact for customers on all quality-related matters.
• Collaborate with Regulatory Affairs on national and international documentation.
• Ensure training and adherence to cGMP and data integrity principles across the team.

Authority :

Delegated authority includes :

• Product batch release

Ideal Profile : Experience :

• 5 years of experience in QA.
• Led teams in the past.
• Good understanding of API and sterile fill / finish.

Core Strengths :

• Rigor, organization, analytical mindset
• Strong communication and leadership skills

Qualifications :

• Science / Engineering degree (BAC +5) or Pharmacist background
• Fluent in English and French
• Experience in GMP pharmaceutical or related industry

If this sounds like you, and you're looking for your next quality challenge - we look forward to your application.