Quality Assurance Manager for Quality Control Laboratories
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 have recently been confirmed as the global manufacturing partner for Moderna’s vaccine against the novel coronavirus, providing a tenfold manufacturing capacity increase. As other businesses face increasing economic uncertainty, we are fortunate to have opportunities for expansion. Through this new collaboration, our work will have a significant, direct and long-term impact on the management of this global pandemic. Become part of this exciting opportunity and join our team by applying for the position as Quality Assurance Manager for Quality Control Laboratories in .
新皇冠体育盘口The Quality Assurance (QA) Manager for Quality Control (QC) ensures the Quality oversight on GMP relevant activities carried out by the Quality Control department. This includes the review and approval of SOPs, analytical methods/specifications and validation plans/reports assuring their compliance to Lonza’s standards, customer’s requirements and health authority expectations. Moreover, as a Quality and Compliance representative, he/she is a key member of cross-functional project teams, e.g. for process transfers and new product introductions.
- Ensure QA oversight for analytical method transfer / validation in dedicated customer projects
- Ensure the continuous implementation of the regulatory requirements and Lonza global policies in the laboratories in Ibex Visp
- Review and Approval of the Validation Master Plan for the QC Equipment qualification
- Review and Approval of equipment SOPs (Standard Operating Procedures)
- Design of the equipment specific qualification together with QC
- Review and approval of qualification documents
- Review and approval of deviations and changes concerning QC equipment
- Represent the Quality Unit in cross-functional teams
- Assist the QC department in developing programs and SOPs to meet current industry standards, internal and external regulatory requirements
- Participate and support regulatory inspections and customer audits
- Bachelor, Master degree or PhD in Analytical Science or related field
- Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within the Quality Unit (QA, QC)
- Strong background in cGMP
- Broad knowledge in QC / analytics (testing of biomolecules preferred)
- Sound experience in representing Quality and Compliance in projects
- 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
- Excellent organizational & self-management skills
- Strong team orientation and solution- oriented way of working
- Fluency in English, German would be an advantage
新皇冠体育盘口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.
新皇冠体育盘口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.