Sr. Manager QA Drug Product (Filling)
Core
Provide leadership and quality oversight for filling operations (equipment prep, formulation, and filling) in a cleanroom environment for SA12 drug product manufacturing.
Role type
Senior Manager, Quality Assurance (Manufacturing)
Builds
Filling lines and drug product batches
Domain
Biopharmaceutical manufacturing (fill/finish)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, regulatory inspection preparation, team leadership, process improvement, cross-functional collaboration
Preferred skills
fill/finish manufacturing experience
Technologies
None stated
Responsibilities
Lead multiple QA teams, oversee equipment prep and filling operations, manage department programs and audits, support team development, serve as escalation point for events
Seniority
Senior, hands-on IC with people leadership