Lead Quality Assurance Manager

Vor 5 Tagen


Sachsen, Deutschland Walker Cole International Vollzeit
Job Description

We are seeking a highly experienced Lead Quality Assurance Manager to join our team at Walker Cole International. The ideal candidate will have extensive knowledge of GxP requirements and experience managing quality assurance teams in the pharmaceutical industry.

Key Responsibilities:
  • Maintain Good Manufacturing Practice (GMP) standards across site operations, ensuring compliance with regulatory guidelines.
  • Strategically plan internal and external audits, including hosting regulatory audits from ANVISA, FDA, EMA, ZMA, and Russian Authorities.
  • Facilitate actions and maintain compliance to systems for change controls, Corrective and Preventive Actions (CAPA's), deviations, and complaints.
  • Lead operational QA activities, including investigating deviations, root cause analysis, and batch record review.
Requirements:
  • 5+ years of experience in Quality Assurance within the Pharmaceutical and Life Sciences industry.
  • Strong working knowledge of GxP requirements.
  • Experience managing a team of QA professionals in a commercial manufacturing environment.

We offer a competitive salary range of $120,000 - $160,000 per annum, depending on experience. Additionally, you will have the opportunity to work with a leading pharmaceutical business in the Saxony region, utilizing your expertise to drive quality excellence.



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