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.
As a Quality Compliance Auditor at Lonza, you'll play a critical role in ensuring the highest quality standards and regulatory compliance in our operations, specifically within the biotech and pharmaceutical sectors. In this capacity, you will perform audits and provide compliance advice, ensuring our operations align with stringent regulatory guidelines. A strong knowledge of regulatory guidelines (FDA and ICH) and quality management systems specific to pharmaceutical and biotech manufacturing is essential. This is remote based role.
Key Responsibilities:
Conduct Supplier Quality assessments/audits and follow up on CAPAs to ensure compliance with pharmaceutical and biotech standards.
Evaluate suppliers’ quality systems using tools like Quality Risk Management (QRM), audits, and trend analysis.
Plan and execute GMP compliance audits for manufacturing sites, focusing on biotech and pharmaceutical sectors.
Advise sites on effective remediation actions to address gaps and ensure compliance with FDA, ICH, and Lonza’s quality standards.
Provide expertise in GMP compliance and support continuous improvement aligned with regulatory standards.
Develop and maintain audit plans, conduct supplier assessments, and generate reports to identify deficiencies and improvement opportunities.
Key Requirements:
Bachelor’s degree or equivalent; Master’s in Science preferred.
5 years of experience in a similar role within the pharmaceutical/biotech industries or at the FDA, focusing on regulatory compliance and auditing.
Experience in regulatory enforcement, public health, or inspection roles, with knowledge of FDA regulations.
Strong knowledge of regulatory guidelines (FDA and ICH) and quality management systems in pharmaceutical and biotech manufacturing.
If you are prepared to compete at a high level and make a meaningful impact, we encourage you to apply for this outstanding opportunity at Lonza AG.
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.