QA Manager Center of Excellence for Commissioning

Vor 6 Tagen

Basel, Schweiz Lonza Vollzeit

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.

As part of Quality SGIE Center of Excellence, this role is aiming to owns all quality related responsibilities for commissioning and qualification (C&Q). Driving and supporting the standardization initiatives to harmonize the C&Q practices within the organization and support transversally the CAPEX projects across the network.

Key responsibilities:

- Be a Subject Matter Expert (SME) on C&Q and provide guidance and recommendations to internal and external customers
- Proactively identify standardization opportunities on C&Q
- Represent Quality in the respective global standards definition, creation and implementation
- Represent Quality in different projects (E.g. roll out of the paperless C&Q system worldwide)
- Support CAPEX projects teams
- Take part to trouble shooting or improvement program and initiatives

Key requirements:

- Master degree in biotechnology, chemistry, life science or related field
- Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit or C&Q
- Proficient experience in stakeholder management and change management
- Broad knowledge in engineering and qualification of equipment, facilities, utilities and related Guidelines (e.g. ASTM, ISPE, GAMP)
- Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
- Excellent English verbal, written and interpersonal communications 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.

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