The role involves performing quality activities to support manufacturing, conducting inspections, ensuring compliance, and leading continuous improvement initiatives.

Provide on‑the‑floor QA oversight for biopharma manufacturing: review batch records, perform line clearance, support QC activities, approve shipments, manage deviations/CAPAs/change controls/investigations/holds, support regulatory inspections, ensure GMP compliance, and maintain document control and procedures.

Support and maintain the Quality Management System (QMS) for compliance with FDA 21 CFR 820, ISO 13485, and MDSAP. Manage CAPA, nonconformance, change control, supplier quality, audits, and investigations. Monitor quality metrics, lead continuous improvement, and partner cross-functionally while providing leadership, training, and support for regulatory inspections and supplier qualification activities.