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Director of Quality Assurance

vor 2 Monaten


Visp, Schweiz Lonza AG Vollzeit

Job Summary:

Lonza AG is seeking a highly skilled and experienced Director of Quality Assurance to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the smooth operation of various mammalian quality control projects.

Key Responsibilities:

  • Oversee quality control projects in the early phases and commercial mammalian projects, from demand to supply to stakeholders.
  • Ensure that monthly deliverables are closely tracked and On Time In Full (OTIF) is secured.
  • Align with lab heads for quarterly OTIF deliverables and anticipate risks and plan for mitigation strategy.
  • Ensure operational readiness of quality control (internal and external) for process performance qualification (PPQ) projects.
  • Serve as a single point of contact for project management (PM) leads for escalations, risks, and issues.
  • Collaborate with internal quality control labs and external partners to mitigate delays and provide necessary support.
  • Handle daily operational batch release updates, progress, and effectively communicate with manufacturing science and technology (MSAT), operations, and quality teams.
  • Connect mammalian manufacturing demand to quality control and flag risks in capacity planning meetings.

Requirements:

  • MSc or PhD in life science biochemistry/biotechnology with significant work experience in the GxP controlled biologics/biopharmaceutical/pharmaceutical industry.
  • Demonstrated stakeholder management skills (collaborating with various types of stakeholders).
  • Strong problem-solving and scientific project management skills (experience in applying lean methodologies is a plus).
  • In-depth knowledge of quality control lab operations and requirements of GxP regulations and guidance of Health Canada, US-FDA, EU.
  • Fluency in English is a must, communication skills in German are an advantage.

About Lonza AG:

Lonza AG is a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.