Senior Quality Assurance Officer mRNA

Netherlands, Geleen

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.

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.

Here at Lonza we have an exciting opening for a Senior Quality Assurance Officer to join us on site in Geleen on a full time, permanent basis.

The Senior Quality Assurance Officer interacts directly with internal customers on change, CAPA and Deviation management, documentation and projects.  The role is to serve as the Lonza Subject Matter Expert and decision maker for change management throughout the facility.   Capable of identifying and resolving quality issues with appropriate supporting documentation.  This level Sr QA officer reviews and approves deviations, CAPAs and CRFs within their assigned area of focus. Sr QA Officers  must be able to weigh the risk of the event and look for an efficient yet compliant solution. The Sr QA Officer provides superior customer service to internal customers.   Mentor and train lower level and new specialists on basic quality tasks.

Key responsibilities:

  • Partner with internal customer as part of moderately complex change control, CAPA, Deviation review serving as the Quality Subject Matter Expert. 
  • Supporting the site as final QA on all change control from the areas of MSAT, Engineering, QC, Validation and Manufacturing. 
  • Attend meetings prepared to speak to the project/change and identify Quality requirements. 
  • Consult with quality management on decisions to ensure alignment and agreement.
  • Completion of QA deliverables associated with change controls (tracking, lot assessments)
  • Review and approve Lonza SOPs, forms, and test methods within Document Management System.  Responsibility is to ensure changes are justified; procedures are followed, and contain appropriate associated reference.
  • Review and approve deviations, CAPAs and CRFs within area of focus
  • Review and approve non DMS documents
  • Lead projects define project plan, scope, and deliverables as assigned.  Manage and track Key Performance Indicator Quality metrics and attend other meetings- represent department at site meetings (when required)
  • Provide guidance to QA Officers.
  • Backup for Manager
  • Suggesting training activities.

Key requirements:

  • Bachelor or Master degree in Science, Biotechnology or related discipline
  • Extensive experience working in GMP environment
  • Extensive experience in Quality Assurance or similar discipline
  • Biotechnology manufacturing background is preferred
  • Knowledge of GMP’s and regulations.  Experienced professional who continues to improve and refine technical knowledge of quality systems
  • Experience with Trackwise, SAP, Document Management system
  • Self-starter, excellent written and verbal communicator at all levels, able to maintain composure, pays close attention to detail, works effectively individually and with all team members.  Able to manage multiple activities within agreed timeframes with a challenging workload and changing priorities

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.

Reference: R35449