QA Compliance 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.
Lonza Verviers is is both a production and distribution site for custom and research media suited to cell therapy and protein production, as well as products for molecular biology and endotoxin detection. The warehouse and distribution facilities also serve as an European sales channel for life-science products manufactured at other Lonza Bioscience sites. We are currently looking to strengthen our quality team with a Quality Assurance Compliance Manager responsible for managing resources and programs to ensure compliance with all applicable cGMP and ISO requirements.
- Manage and maintain compliance of Verviers Site to the Lonza Quality Systems, applicable quality regulations, guidance documents, industry standards, and customer expectations.
- Manage and oversee the personnel responsible for performing quality audits and for monitoring site compliance to standard operating procedures and other site documentation, appropriate regulations, and industry standards.
- Assess product, compliance, or operational risks and develop risk management strategies.
- Identify compliance issues that require follow-up or investigation and conduct or direct the internal investigation of compliance issues
- Facilitate customer and regulatory agency audits at Lonza Verviers. and respond in writing to audit observations. Ensure follow up activities
- Keep informed regarding pending industry changes, trends, and best practices and assess the potential impact of these changes on organizational processes. Review or modify policies or operating procedure to comply with changes to standards or regulations
- Maintenance of Quality Systems according to ISO or cGMP requirements.
- Ensure compliance with Regulatory requirements for Medical Devices and CE Marked products.
- Master’s degree in pharmacy, chemistry or biology
- Extensive GMP experience in the pharmaceutical industry, with multiple years direct QA experience and a first management experience
- Fluency in French and English
- You are able to handle multiple assignments simultaneously, have excellent oral and written communication and display good organization skills.
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.