Director, Quality Operations
Core
Lead strategic quality operations and oversight for clinical and commercial oncology programs, ensuring product quality from development to commercialization.
Role type
Director, Quality Operations (Pharmaceutical/Biotech)
Builds
Oncology therapeutics (small molecules and biologics, including ADCs)
Domain
Oncology / Biopharmaceuticals / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, CAPA management, change control, vendor qualification, regulatory inspection readiness, risk assessment, continuous improvement, quality governance, outsourced manufacturing oversight
Preferred skills
ADC development experience, global regulatory inspection leadership, commercial operations support
Technologies
GMP systems, Quality Management Systems (QMS), regulatory submission tools
Responsibilities
Oversee quality aspects of manufacturing (starting material, intermediates, drug substance/product, packaging); Review and approve product specifications and master batch records; Manage CAPA, deviations, and change controls; Ensure inspection readiness for FDA and international audits; Drive continuous improvement initiatives and operational metrics; Lead quality governance and cross-functional collaboration
Seniority
Director, strategic leadership with hands-on operational oversight
