Associate Director, Quality Control Specialist

vor 2 Wochen

Visp, Schweiz Lonza Vollzeit
Job Summary

Lonza is seeking an experienced Associate Director, Quality Control to lead the operational aspects of all projects within the Mammalian business unit. This role will be responsible for anticipating and addressing risks, ensuring the smooth operation of various mammalian QC projects, and aligning with lab heads for quarterly OTIF deliverables.

Key Responsibilities:
  • 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.
  • Serve as a single point of contact for reviewing business proposals and ensure that work-packages can be delivered by QC within the agreed time frame with the business.
  • 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.
  • Highlight the anticipated risk to the Project Management that impacts the service delivery.
Requirements:
  • MSc or PhD in Life Science Biochemistry/Biotechnology with significant work experience in the GxP controlled Biologics/Biopharmaceutical/Pharmaceutical industry is a must.
  • Demonstrated stakeholder management skills (collaborating with various types of stakeholders).
  • You enjoy risk and issue management. You enjoy challenges and you are eager to make an impact to our organisation. You also enjoy working in a dynamic environment.
  • Strong problem solving and scientific project management skills (experience in applying Lean methodologies is a plus, e.g. 5Why, 6M).
  • 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.
  • Relocation assistance is available for eligible candidates and their families, if needed.

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