Director of Quality - Biologicals and Chemicals Division
Core
Global quality leadership for the Cell Culture Media Network, ensuring compliance, harmonization, and continuous improvement across multiple manufacturing sites.
Role type
Director of Manufacturing Quality (Global)
Builds
Manufacturing Quality function and product quality across a global network of sites
Domain
Life Sciences / Biologics and Chemicals Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, ISO 13485, FDA 21 CFR 820, MDSAP, Quality Management Systems, Lean Six Sigma, cross-functional leadership, multi-site governance, complaint management, regulatory audit preparation
Preferred skills
Advanced degree in Science or Engineering, experience in global matrixed organizations
Technologies
None stated
Responsibilities
Lead network-wide Manufacturing Quality strategy; Ensure compliance to global standards (ISO, FDA, MDSAP); Drive harmonization of Quality processes and metrics; Own product Quality performance KPIs; Lead and develop global Quality teams; Partner with Operations, R&D, and Regulatory Affairs; Oversee complaint and nonconformance management; Lead customer and regulatory interactions; Enable readiness for capacity expansion and new product introductions
Seniority
Director, strategic leadership & multi-site governance
