Quality Assurance Manager Jobs

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Quality Assurance Manager
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🧭 Full-Time

💸 105000.0 - 125000.0 USD per year

🔍 Biopharmaceutical

  • Bachelor’s degree or equivalent in life sciences or healthcare.
  • Over ten years of experience in the pharmaceutical or biotech industry.
  • Extensive QA operation experience with GMP/GDP knowledge.
  • Strong understanding of regulations, especially Annex 13, APAC, LATAM.
  • Fluency in spoken and written English.
  • Ability to travel approximately 25% of the time.
  • Knowledge of GMP, GDP, and GCP requirements.
  • Coordinate a Quality team for IMP compliance.
  • Set goals and conduct performance reviews.
  • Manage KPIs for QA activities related to IMP suppliers.
  • Act as central contact for inquiries, deviations, investigations, and audit observations.
  • Ensure compliance with change requests and complaints.
  • Maintain all quality agreements and collaborate for adherence.
  • Work cross-functionally with internal teams on quality issues.
  • Participate in supplier QA meetings to present issues and guide resolutions.
  • Review batch records for clinical trials.
  • Support supplier audits and ensure readiness for inspections.

Quality Assurance

Posted 3 months ago
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