Site Quality Head, Morrisville (Director)
Core
Lead the independent site Quality organization for a new Small Molecule manufacturing site through ramp-up and commercialization, ensuring regulatory compliance and operational excellence.
Role type
Senior IC Site Quality Head (Director)
Builds
New Small Molecule manufacturing site operations
Domain
Pharmaceutical manufacturing (Small Molecule)
Required skills
Pharmaceutical Quality Assurance, Quality Control, cGMP compliance, Regulatory inspection leadership, Quality Management Systems (QMS), Risk Management, People leadership, GxP oversight
Preferred skills
Operational excellence, Continuous improvement, New facility ramp-up experience
Technologies
GxP, cGMP, ISO standards, QMS
Responsibilities
Lead the independent site Quality organization; Establish and maintain the site Quality Management System (QMS); Ensure compliance with cGMP and regulatory requirements; Lead Health Authority interactions and regulatory inspections; Recruit and develop a high-performing Quality organization; Serve as a key member of the Site Leadership Team.
Seniority
Director, strategic leadership with hands-on oversight
