Senior Manager/Associate Director, Quality Operations

Role: Sr. Manager/Associate Director of Quality Operations overseeing external drug product manufacturing and lifecycle activities for TG Therapeutics' biologics portfolio, including commercial and clinical-stage products. Responsibilities: provide quality oversight of CMOs and GMP suppliers, lead batch disposition, evaluate complex manufacturing issues, review deviations, investigations, and validation activities; support technology transfer, process validation, and supplier governance; ensure inspection readiness and continuous quality improvement; manage Quality Agreements, audits, and regulatory interactions; collaborate cross-functionally to support product supply and compliance; and lead quality performance metrics. Requirements: minimum 7 years in GMP Quality or biologics manufacturing, with experience overseeing CMOs and supporting commercial manufacturing; thorough knowledge of cGMP regulations, Quality Systems, batch release, deviations, CAPAs, and validation; proficiency with electronic QMS platforms (e.g., Veeva); strong analytical, communication, and leadership skills; ability to operate independently with minimal oversight. Preferred: experience with regulatory inspections (FDA, EMA), interaction with Qualified Persons (QPs), and post-graduate education. HighValue: biologics manufacturing, commercial and clinical-stage, lifecycle management, cGMP compliance, supplier governance, validation, inspection readiness, and quality oversight of drug product and secondary packaging. Work setup involves some travel (~15%), with a focus on maintaining compliance and product quality across external manufacturing sites.