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 storage operations at CMOs (drug product, including active and placebo lots), and serving as Labelling/Packaging SME and Quality point of contact for future internal operations Qualifying CMOs, service providers, and suppliers, and negotiating and maintaining Quality Agreements with them Partnering with Procurement, Operations, QC, Supply Chain, Process Development, Legal, and external partners on CMO selection, qualification, and management, and aligning on quality topics across CMC programs Supporting oversight of CMO and supplier quality activities, including deviations, change controls, complaints, master batch record (MBR/eBR) review, and batch disposition/release Acting as Person-in-Plant (PIP) during manufacturing campaigns, serving as the on-site quality authority to make real-time, risk-based decisions, escalate critical issues, and protect GMP compliance and product quality Performing quality risk assessments, developing mitigation plans, following up on implementation, and escalating critical quality issues for timely resolution at program and leadership level Maintaining CMO site readiness for Health Authority inspections and for internal, partner, and third-party audits, participating in GMP audits of CMOs and suppliers, and monitoring inspection and audit outcomes to ensure action plans are implemented Evaluating and driving CMO and supplier audit responses and CAPAs, ensuring actions fit the root cause, are effectively implemented, and are verified through to closure Monitoring and reporting quality performance metrics, driving continuous improvement initiatives, and staying current on applicable quality…