Senior Supplier Quality Professional
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
We are currently looking for an experienced Senior Supplier Quality Professional to be join us in Basel.
The Senior Supplier Quality Professional will be acting as Single Point of Contact (SPOC) for assigned suppliers from a global portfolio on behalf of Regional Head. To ensure the uninterrupted supply of materials and services to Lonza by assessing the quality of the Suppliers and their ability to meet defined requirements utilizing tools such as Quality Risk Management (QRM), supplier assessment/audit, change management, and complaint/deviation trend management.
- Perform Supplier Quality assessments/ audits of Suppliers and Contractors to annual plan and follow up on agreed upon CAPAs.
- Conclude quality assurance agreements and follow up of results with Lonza Sourcing and stakeholders. Ensure that Change requests, either from the Supplier or from Lonza are managed according to the Quality Agreement and Lonza SOPs from receipt, through to the implementation and closure.
- Assure issues are timely classified, communicated to the supplier and to key stakeholders.
- Promptly notify and escalate to Regional Head Supplier Quality any potential quality or regulatory issues that may affect product quality or regulatory compliance
- Participate in the Reporting on QA Supplier performance - this is to include Risk Assessment ranking and managing of defined KPI’s. Monitor Key Performance Indicators and ensure work is performed in a consistent manner against harmonized expectations. Initiate corrective actions when necessary and perform follow-up on resulting measures.
- Support Lonza QMS and SOPs for Global Supplier Quality as assigned.
- Responsible for mitigating quality trends and driving continuous improvement for processes and product quality performance for assigned suppliers. Support Regional Head to find solutions to complex manufacturing, quality and negotiation problems.
- Perform other duties as assigned.
What we need you to have:
- University/academy degree in Biochemistry, Chemistry, Pharmacy, Microbiology or equivalent.
- Extensive experience in the pharmaceutical, biopharmaceutical or related industry
- Strong knowledge in cGMPs requirements, ISO standards and understanding of regulatory requirements
- Proven track record with FDA, EMEA and other Health Authorities
- Auditing experience (internal / external) manufacturing facilities, equipment, laboratories and service providers)
- Experience in Supplier Qualification and Supplier Monitoring
- Strong understanding of risk assessment and risk management fundamentals/tools
- Preferably auditor certification by an industry recognized body e.g. ASQ
- Languages: Fluent in speaking / writing in English other languages desirable
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.