Associate Director- QA at Lonza Inc. in Houston, Texas

Job Description:

Associate Director Quality Strategy and Operations

Location: Houston, Texas In-office

Lead quality strategy and operations at Lonza AG, playing a crucial role in delivering world-class life science solutions. Our global leadership in life sciences empowers teams to innovate and make a difference in a collaborative and inclusive culture.

Key responsibilities:

• Implement the overall quality strategy for facility expansion projects.




• Collaborate with the Site Director, Head of Quality, and Senior Leadership Team to ensure alignment with Manufacturing and support functions in implementing the strategy.




• Act as the lead Quality SME for significant quality or compliance issues within the facility expansion projects.




• Identify and implement QA improvement projects for Cell Therapy and Viral Vector assets, following global quality systems and regulatory requirements (e.g., US FDA and European).




• Collaborate across the quality function to improve the Quality Operations/Quality Control customer interaction models in order to improve the overall customer experience.




• Coordinate the consolidated Quality reporting on behalf of the site and assets in accordance with global system requirements.




• Drive cross-functional collaboration on Quality Strategic projects for Assets and align with Site Business Strategy.




• Ensure financial excellence in Quality.




• Manage timely handling of blocking issues on behalf of the site in accordance with Lonza Group Procedures.




• Coordinate all Staff projects on behalf of the Site QA Head.

Key requirements:

• Bachelor's degree in Life Sciences or Engineering field is required.




• Equivalent experience to a Master's degree is preferred.




• Advanced Experience (5-10 years) in biopharmaceutical manufacturing experience and/or quality operations or quality systems working in a GMP environment.




• Experience in aseptic processing.




• Knowledge of regulations (US, EU, and other).




• Experience in a biopharmaceutical manufacturing or Quality Control environment or other relevant experience.




• Proven experience in managing complex business setups and projects.

Join us at Lonza AG, where your ideas can genuinely improve the world. Be part of a team that values ethical success, inclusivity, and the happiness of making a meaningful difference.

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.