offre-emploi


Quality Assurance Manager > Joboolo FR :


Société : Metric Bio
Lieu : Saint-Priest 69005

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

  • Product recall decisions



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.


Metric Bio
Saint-Priest 69005
Autre(s)
VIE
0 mois





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