Oorspronkelijke vacature omschrijving:

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.

In order to support the strategic growth investment of the company in Geleen, Netherlands, we are looking for a senior quality leader responsible for the quality oversight during project initiation and execution (equipment, utilities, facility commissioning & qualification) for a major CAPEX project.

Key responsibilities:

• Owning all quality related responsibilities for the CQV Lifecycle Program activities of dedicated new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs.
• Being a Subject Matter Expert (SME) and providing guidance and recommendations to internal or external customers
• Representative of Quality in the CAPEX project organization in regards to CQV
• Review and release of CQV plans, documents and SOPs
• Responsibility for project change and deviations
• Leading and supervising a small project team to meet project timelines

Key requirements:

• Master of Science in Bio-Engineering or a related field
• Experience working in a GMP related environment in the pharmaceutical industry
• Several years of proficient work experience in a Quality Unit within Biologics
• Proficient experience in Stakeholder Management
• Fluency in English, German and/or Dutch would be an advantage
• Experience on Regulatory inspections
• Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit
• Strong background in cGMP
• Broad knowledge in engineering and qualification of equipment, facilities, utilities (biopharmaceuticals) 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 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.