Quality Assurance Project Manager Drug Substance
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 GMP Training Manager in Visp, Switzerland.
The Quality Assurance Project Manager Drug Substance is an experienced QA professional with broad background, especially in the context of biotechnological manufacturing of drug substances, and extensive expertise in cGMP, including international regulations. In this role, you will be a member of a small QA team that will ensure the quality oversight of a new facility and drug substances produced therein. You will be involved in transfers of manufacturing processes, maintain contact with customers and release or reject drug substances on behalf of the Responsible Person.
- Be involved in all facility start-up activities as well as process transfers
- Facilitate discussions between customers and internal teams such as MSAT (Manufacturing Science & Technology), Manufacturing, Engineering and Quality Control
- Review and approve Discrepancy Records and Change Requests
- Manage the process for notifying the customer about discrepancies / change requests and assuring the customer’s feedback and relevant comments are addressed internally
- Support the definition of preventive and corrective measures (CAPAs), approve them and track their timely implementation and effectiveness
- Release Drug Substance batches
- Represent the Quality Unit in cross-functional teams
- Review and approve SOPs and project related documents; support and approve quality risk analysis (e.g. FMEA)
- Write or revise SOPs in your area of expertise and act as Owner of such documents
- Support cGMP training programs to ensure staff is trained
- Be involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department
- Actively support the Quality culture as a role model
- Bachelor in Biotechnology, Biology, Chemistry or other natural science
- Substantial experience in the area of biopharmaceutical manufacturing
- Broad knowledge of biotechnological manufacturing processes (especially microbiological biotech processes) as well as in cGMP
- Sound experience in representing Quality and Compliance in projects
- Good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies
- Strong team orientation and solution-oriented working approach
- Structured, focused and well-organized working attitude
- Open-minded for new ideas and suggestions
- Agile, highly motivated and dynamic drive
- Fluency in English, German would be an advantage
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.