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.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Team Lead QA Qualification and Validation 80-100% (m/f/d) being responsible to lead the QA qualification and validation team for our Strategic Growth Project in Lonza DPS Stein.
Key responsibilities:
- Act as QA Point of Contact providing Quality Oversight for all equipment and system qualification and validation executed for the DPS growth projects
- Lead, build and manage a team of QA qualification, validation, CSV and DI experts and develop the team according to Lonza policies
- Ensure the proper qualification, requalification and validation of equipment/infrastructure/computerized-systems by adherence to the corresponding VMP(s), calibration and maintenance plans and to Lonza local quality procedures
- Supervise compliance activities like GMP status and trending of equipment, qualification/re-qualification in relation to supplier qualification, changes, non-conformities, CAPAs, audit/inspection/self-inspection observations, document management; vendor change notification; participation in audit/inspection/self-inspection
- Collaborate with other sites and global teams to improve and align the CQV processes within Lonza
- Act as first contact concerning compliance issues for equipment/infrastructure/computerized-systems qualification in shared global systems (e.g. LIMS, DMS, SAP, COMOS, Unifier, Trackwise)
- Work with the DI experts on site to continuously improve the DI Maturity Level of the DPS growth projects
Key requirements:
- Academical degree (Bachelor or higher) in a Life Sciences, Engineering; IT Systems, Industrial Engineering or related science discipline
- Minimum of 10 years of experience in qualification and validation within a GMP regulated environment
- Significant working experience in a QA role within the pharma industry
- Strong leadership skills (strong team orientation) and ability to communicate internally and externally at higher levels, strong business understanding
- Aseptic production experience is desired
- Data Integrity mindset is a must
- Fluency in English and German
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.