Manager, Product Quality

Job Summary

To support the mission of developing therapies for autoimmune diseases, the remote Senior Manager / Manager, Product Quality will ensure compliant documentation of CMC activities, develop Quality Systems, and collaborate with cross-functional teams in clinical and commercial operations.

Key responsibilities

• Collaborate with CMC, Supply Chain, and Clinical Operations for the release of Clinical Trial Material (CTM) and support global supply disposition
• Assist in analytical needs, method validation, and product validation for clinical and commercial drug supply
• Develop and implement procedures for the Quality Management System (QMS) and support audits as necessary

Required qualifications

• 6-12 years of experience in the biopharmaceutical industry or related field with GMP Quality experience
• Experience with US and global clinical studies across various development stages
• Knowledge of US commercial Quality and DSCSA compliance
• Experience with oral solid dose Quality preferred
• Ability to independently audit various operations and work with external vendors