Sr. Quality Assurance, Customer & Project Lead

The Senior Quality Assurance, Customer & Project Lead is an experienced individual contributor responsible for executing customer-facing Quality activities and completing assigned Quality deliverables across development, validation, commercial manufacturing, and product lifecycle programs in a CDMO environment. The role reports to the Senior QA Manager, Customer Quality & Project Assurance and works directly with Project Management, Manufacturing, Quality Control, Regulatory Affairs, Technical Services, Validation, Supply Chain, and other functions to meet customer commitments while maintaining cGMP compliance.

The position performs the detailed Quality work within the manager’s scope, including customer communications, project quality tracking, batch disposition support, quality event follow-up, complaints, CAPAs, customer audits, APQRs/PQRs, Quality Agreements, dashboards, and commitment closure. The role exercises independent Quality judgment within approved procedures and escalates significant compliance, product, patient, schedule, and resource risks to management.