Senior Quality Systems & Compliance Project Manager

Today, Lonza is a global leader in life sciences operating across five 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.

Key responsibilities:

• Identify and lead the implementation of quality improvement projects to improve performance and compliance at the site.

• Lead follow-up assessments from Health Authority, customer, and internal audit observations within the Lonza network.

• Conduct lessons learned sessions from case studies from Lonza Houston and the Lonza Network.

• Implement inspection readiness actions and train the Houston workforce on inspection readiness needs.

• Coordinate the implementation of new or revised global compliance programs and standards at Lonza LHI.

• Partner with site functions to implement a quality culture program.

• Scope and manage projects focusing on QMS and compliance needs at Lonza Houston Site.

• Collaborate closely with all assets and functions to ensure accurate deviation trending, root cause analysis, and CAPA efficiency.

• Act as a strong partner to the Manufacturing Operations teams (Viral Vector & Cell Therapy) and other supporting teams (e.g., QC, Materials Management, Engineering, Validation, and Quality Systems).

Key requirements:

• Bachelor's in Life Sciences, Engineering, or related field.

• Advanced experience in biopharmaceutical manufacturing and/or quality operations within a GMP environment.

• Background in business administration, project management, and Lean/Six Sigma management is a plus.

• Proven ability to analyze data and extract essential information to inspire change.

• Experience with regulations (US, EU, and others).

• Experience in a biopharmaceutical manufacturing environment or industries with high reliability needs (e.g., aviation industry).

• Proven experience in managing complex business setups and projects.

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.