Senior Director, Quality Assurance, Commercial
Core
Lead commercial manufacturing quality assurance for a neuroscience biopharmaceutical company, ensuring GMP compliance for drug substance, drug product, and finished goods across CMOs and internal operations.
Role type
Senior Director, Quality Assurance, Commercial
Builds
Commercial small molecule products (solid oral dosage, finished goods) for patients with epilepsy, depression, and pain
Domain
Biopharmaceuticals / Neuroscience / Small molecule manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP quality leadership, small molecule manufacturing expertise, CMO management, global GxP knowledge, Qualified Person (QP) requirements, quality system metrics, cross-functional project leadership, supplier auditing, team management
Preferred skills
Advanced degree in life sciences, experience with virtual manufacturing partners
Technologies
GxP systems, CMC tools, quality metrics platforms
Responsibilities
Lead commercial manufacturing, testing, and disposition activities at CMOs; manage global QA teams; collaborate with CMC and Supply Chain on cGMP compliance; implement strategic quality system improvements; represent Quality function in Health Authority inspections and supplier meetings; recruit and develop direct reports
Seniority
Senior Director, strategic leadership with hands-on management