Manager, Quality Control

Role: Manager, Quality Control, overseeing analytical functions at Vertex Manufacturing and Leiden Centers for testing, reporting, and cGMP compliance. Responsibilities: manage laboratory programs, ensure timely execution, coordinate sample management, author/review data and SOPs, lead investigations and continuous improvement initiatives, and serve as QC representative in cross-functional teams. Requirements: Bachelor's in science with 8+ years in biopharmaceutical/industry QC management; strong knowledge of analytical methods (flow cytometry, sterility, endotoxin, cell culture), US/EU cGMP regulations, and experience with regulatory inspections. Preferred qualifications include prior QC management experience and effective communication skills. High-Value: biological modalities supporting cell/gene therapies or biologics, night shift (Wednesday-Saturday, 9pm-9am), third shift role, on-site with flexible ad hoc options. No travel specified. Collaboration: cross-departmental, vendor interactions, and quality investigations.