Quality Sterility Assurance Manager

United States, Houston (Texas)

Quality Sterility Assurance Manager

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. 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.

The new state of the art Houston, TX facility is looking for a Quality Sterility Assurance Manager for Quality Assurance. In this role you will be responsible for quality assurance oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Cell Therapy and/or Viral Therapy Operations. This 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.

Key responsibilities:

  • Provide strategic plan and expertise for the development and implementation of the site Sterility Assurance Program.  
  • Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.
  • Lead Sterility Assurance Board
  • Provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements.
  • Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes.
  • Provides microbiological expertise to support EENs, deviations, CAPAs and complaints related to aseptic processing.
  • Supports regulatory and client audits as Aseptic Sterility Assurance subject matter expert.
  • Provide microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations and specifications.
  • Managing a staff of 1-2 specialists and provide guidance, oversight and support for Operations and QA/QC specialists

Key requirements:

  • Bachelor’s Degree in Life Sciences
  • Experience with regulations (US, EU and other)
  • Experience in a bio pharmaceutical manufacturing environment
  • Experience in an aseptic manufacturing environment
  • Highly experienced in Bio pharmaceutical manufacturing and/or aseptic processing working in a GMP environment
  • Advanced experience in Aseptic Processing
  • Advanced experience managing a Quality Assurance staff

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. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R28288