QA Qualification Manager

Belgium, VerviersToday, 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.

As QA Qualification Manager for the Verviers, Belgium | Lonza site, you ensure compliance with all applicable cGMP and ISO requirements. You also ensure 21 CFR part 11 and 21 CFR 820 compliance, Eudralex vol IV annex 1. You are responsible for the Qualification and Requalification of a family of Equipment, Utilities. You are leading a small team, this includes the Training of Personnel, the planning Management, the participation in the elaboration of operating budgets, as well as the daily aspects of a team’s life.

Key responsibilities:

- Ensure compliance with all applicable cGMP and ISO requirements.
- Participate in the management of compliance-critical functions including quality systems, change control, training, Internal audit, validation support, document control, supplier quality, quality agreements, computer system validation, E&M documentation and regulatory and customer audit program for the site.
- Participate in projects within the department and with other departments to identify and implement quality improvement projects and policies.
- Exercises judgment with in broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Ensure compliance with all applicable internal and external guidelines and standards.
- Works on complex problems where analysis of situations or data requires an in depth evaluation of various factors.
- Participate in the management of compliance critical functions including quality systems, change control, deviations, training, internal audit, validation support, document control, supplier quality, quality agreements, computer system validation, E&M documentation and regulatory and customer audit program for the site.

Key requirements:

- Master in engineering or related field
- Fluent in French and English
- Significant experience in pharmaceutical, biotechnology or related industry
- Substantial experience in equipment qualification and in QA
- GMP compliance knowledge including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others
- Supports a culture of process improvement and problem solving
- Demonstrates an openness to trying new approaches

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.

**Reference: R53093**: