Quality Site Head, Oceanside
Core
Design, qualification, and ramp-up of a greenfield high-volume biologics manufacturing facility, ensuring full GMP/Quality compliance and leading the Quality organization.
Role type
Senior Quality Site Head (Greenfield Facility Start-up)
Builds
Commercial-scale biologics drug substance and drug product manufacturing operations
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
GMP compliance, Quality Assurance/Control leadership, project management, organizational change management, safety systems, cGMP application, strategic workforce planning, process improvement
Preferred skills
Advanced degree (Masters/PhD), international multi-site experience, lean/agile methodologies
Technologies
Single-use manufacturing systems, dual stainless steel systems, IT systems for quality
Responsibilities
Lead the Quality part of the User Team during facility start-up and transition to routine operations; drive timely project execution with strategic thinking; foster a strong mindset for safety, quality, and compliance; take purposeful decisions; manage personnel promotion, deployment, training, appraisals, and performance goals; build partnerships with internal and global Quality organizations.
Seniority
Senior, hands-on IC with strategic leadership