Senior GMDP Quality Assurance Manager
Core
Senior leadership for site quality assurance supporting pharmaceutical distribution and manufacturing activities, including secondary packaging and labelling.
Role type
Senior GMDP Quality Assurance Manager
Builds
Compliant delivery of client solutions for Post Approval Named Patient/Expanded Access Program and Clinical Trial supply services
Domain
Pharmaceutical manufacturing and distribution (GMP/GDP)
Required skills
GMP/GDP compliance, risk-based quality management, QMS operation, deviation/CAPA/change control management, secondary packaging oversight, warehouse quality reviews, regulatory inspection readiness, team leadership, stakeholder management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Oversee day-to-day site quality operations and Quality Management System; Lead risk assessments and corrective actions; Provide hands-on quality oversight of warehouse distribution and manufacturing; Complete critical warehouse reviews as Responsible Person; Lead site inspection readiness and audit responses; Coach and manage the QA site operations team; Provide quality leadership for client communications and recalls
Seniority
Senior, hands-on IC with people management