Research Development Quality Assurance Manager

Vor 7 Tagen

Köln, Nordrhein-Westfalen, Deutschland Catalyst Life Sciences Vollzeit

Job Summary:

Catalyst Life Sciences is seeking a highly skilled Quality Assurance Leader to support our global R&D functions. As a key member of our team, you will play a crucial role in providing QA leadership and guidance for new R&D projects at our cutting-edge facility.

Key Responsibilities:

  • Attend project meetings and provide QA support to ensure compliance with stringent GMP standards.
  • Review analytical reports and assay results to ensure accuracy and quality.
  • Collaborate with project teams to establish robust quality agreements and perform thorough quality risk assessments.
  • Provide technical support from a QA perspective to project teams and align quality objectives with financial goals.
  • Collaborate with the finance department to ensure quality objectives are met.
  • Develop and implement quality systems to ensure compliance with regulatory requirements.
  • Lead and influence quality strategies on a global scale to support new product development, registrations, and technical transfers.

Requirements:

  • 3-5 years of hands-on experience in GMP quality assurance within the pharmaceutical industry.
  • Demonstrated understanding of regulatory requirements and quality systems.
  • Fluent in both German and English, enabling effective communication and collaboration across international teams and stakeholders.
  • Proficiency in Veeva systems is a plus.

What We Offer:

Catalyst Life Sciences offers a dynamic and innovative work environment where you can leverage your expertise in QA to drive innovation and ensure regulatory compliance in pharmaceutical development.

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