QA Associate Director (ADC)
Core
Establishing and maintaining the Quality Management System for Antibody-Drug Conjugate (ADC) products to ensure regulatory compliance and product quality safety.
Role type
Senior Director, Quality Assurance (Pharmaceutical/Biologics)
Builds
ADC products compliant with GMP and regulatory standards
Domain
Pharmaceutical industry, Antibody-Drug Conjugates (ADC), Biological products
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, Quality Management System (QMS) design, Contract Manufacturing Organization (CMO) oversight, Supplier qualification, Product release management, Quality risk management, Cross-contamination control, Self-inspection system establishment, Regulatory reporting (NMPA/EMA/ICH)
Preferred skills
MAH (Marketing Authorization Holder) system operation experience, ADC or biological product quality management experience
Technologies
GMP, ICH guidelines, NMPA, EMA regulations
Responsibilities
Oversee QMS for ADC products and contract manufacturing; Evaluate and inspect CMOs and material suppliers; Manage product release and batch analysis; Conduct quality risk assessments and post-marketing change controls; Ensure compliance with pharmaceutical laws and regulations.
Seniority
Director, strategic oversight with hands-on technical expertise