QA Process Validation Manager

Switzerland, Visp

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.Therefore we a looking for a QA Process Validation Manager in Visp, Switzerland

Key responsibilities:

  • Issue process validation/ study protocols and reports (incl. hold time studies and leachable & extractable studies)

  • Participate in or moderate cross-functional Risk Assessments to define the scope of validation/ study activities

  • Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures

  • Be involved as Subject Matter Expert in the execution of Discrepancy Records and Change Requests

  • Represent the Quality Unit in cross-functional teams

  • Assist the department in developing programs and SOPs to meet current industry standards, internal and external regulatory requirements

  • Participate and support regulatory inspections and customer audits

Key requirements:

  • Bachelor, Master degree or PhD in Chemistry, Biotechnology, Life Sciences or related field

  • Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within the Quality Unit

  • Broad knowledge in biotechnological manufacturing processes, validation approaches and risk management

  • Good communication skills and experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)

  • Fluency in English, German would be an advantage

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.

Reference: R21192