External QA Specialist/Manager
Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.
We're looking for an experienced External QA Specialist/Manager to join our Supplier Quality Management team and help ensure the quality of the Contract Manufacturing Organizations (CMOs) behind our monoclonal antibody programs. In this role, you'll provide quality oversight of the CMOs involved in manufacturing our monoclonal antibodies, including clinical and commercial batch manufacturing, labelling, packaging, and storage. You'll be involved across the full CMO lifecycle, from selection and qualification through ongoing management and decommissioning. You'll also support risk-based quality oversight of our broader network of suppliers and service providers, helping ensure they are properly qualified, consistently overseen, and compliant over time. If you're a QA professional who enjoys building strong partnerships with external manufacturers and takes pride in keeping quality at the center of every handoff, we'd love to hear from you.
How you might spend your days
- Providing quality oversight of clinical and commercial packaging, labelling, and s