Gerente de la Unidad de Calidad
Core
Lead, implement, and maintain a Quality Management System aligned with EU-GMP, US-GMP, and applicable regulations for a pharmaceutical manufacturing plant.
Role type
Senior Quality Unit Manager (Pharmaceutical Manufacturing)
Builds
Pharmaceutical products (small molecules, biologicals, imaging contrast agents, OTC)
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Required skills
GMP compliance (EU/US), Data Integrity management, CAPA implementation, Quality audit preparation, Change management, Risk assessment, Budgeting, Team leadership, Regulatory updates
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead and implement a Quality System aligned with EU-GMP and US-GMP; Ensure compliance with Data Integrity regulations; Prepare for and defend agency inspections and client audits; Establish internal and supplier audit systems; Coordinate change management, complaints, and risk analysis; Set quality objectives and track metrics; Manage the quality team, resources, and training plans; Report quality evolution and risks to senior leadership; Ensure equipment and facilities are validated and maintained.
Seniority
Senior, hands-on IC
