Líder de Auditorías
Core
Leading internal audit programs and regulatory inspection readiness for a pharmaceutical manufacturing site to ensure GMP compliance and quality integrity.
Role type
Senior Quality Assurance Audit Leader
Builds
Internal audit programs, regulatory inspection responses, and quality certification documentation
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
Required skills
GMP knowledge, internal audit management, regulatory inspection coordination, CAPA management, quality system administration, pharmaceutical legislation expertise, technical leadership
Preferred skills
Experience with FDA/EMA/COFEPRIS inspections, multinational environment experience, team administration
Technologies
SAP, GCM, OCM, TW, GAM, Microsoft Office Suite
Responsibilities
Lead the internal audit system and annual audit program execution; Execute and follow up on internal and external quality audits; Coordinate and lead regulatory agency inspections; Manage regulatory communication and technical documentation submission; Support Regulatory Affairs with authority responses; Promote a preventive quality culture.
Seniority
Senior, hands-on IC
