Associate Director, QA Sterility Assurance - LSA

Today, Lonza is a global leader in life sciences operating across three continents.' needs to be changed to 'Today, Lonza is one of the world's largest healthcare manufacturing organizations operating across five continents.

Requirements

• Responsible for QA oversight of Aseptic Processing Program , Environmental Monitoring and Microbial Control Policies for the Cell Therapy and/or Viral Therapy Operations.
• Individual should be able to work independently with little direction to review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures.
• Review of sterile filter validations, integrity testing and procedures is also required.
• The individual is expected to interact with Cell and Viral Therapy Operations Management, QC and QA leadership.
• Primary responsibility is to maintain sterility assurance of Aseptically manufactured sterile drug products and viral vector products.

Requirements

• Bachelors Degree in life sciences field
• 7-10 years of experience