Associate Director, Quality Control Specialist

vor 4 Wochen

Visp, Schweiz Lonza Vollzeit
Job Summary

We are seeking an experienced Associate Director, Quality Control to join our team at Lonza. As a key member of our Quality Control department, you will be responsible for overseeing the operational aspects of all projects within the business unit Mammalian, specifically for risk and issue management.

Key Responsibilities
  • Anticipate and address risks to prevent escalations and ensure smooth operation of various mammalian QC projects.
  • Oversee QC projects in the early phases and commercial Mammalian projects, from demand to supply to stakeholders.
  • Ensure 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.
  • Responsible to closely track the progress of critical deliverables having financial impact on business.
  • Ensure operational readiness of QC (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 QC Labs and external partners to mitigate delays and provide necessary support.
  • Responsible to follow up with labs for OOS, Deviations which has an impact on batch release timelines.
  • 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 QC 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).
  • Enjoy risk and issue management.
  • Enjoy challenges and eager to make an impact to our organisation.
  • Strong problem solving and scientific project management skills (experience in applying Lean methodologies is a plus).
  • In depth knowledge of QC lab operations and requirements of GxP Regulations and guidance of Health Canada, US-FDA, EU in particular data integrity and various compendia (USP, EP, JP).
  • Fluency in English is a must, communication skills in German are an advantage.
About Lonza

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.

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