Assoc Dir Quality Function
Core
Ensures quality and compliance of products marketed in Brazil, Chile, Uruguay, and Mexico, adhering to corporate and local regulatory standards and GxP requirements.
Role type
Senior Associate Director, Quality Assurance (Biopharmaceuticals)
Builds
Quality systems, regulatory compliance frameworks, and product lifecycle management for generics in Latin America
Domain
Biopharmaceuticals / Generics / Regulatory Compliance
Required skills
Active Pharmacist License (CRF), Good Manufacturing Practices (GMP), Good Storage Practices, RDC No. 658/2022 knowledge, Analytical testing (QC), Supplier audits, Corporate audits, Deviation management, CAPA, Market complaints, Product recalls, Quality crisis management, KPI governance, People management, Budget management
Preferred skills
Import and distribution business model, Quality Laboratory experience
Technologies
GxP, RDC No. 658/2022, Quality Councils, KPIs
Responsibilities
Ensure implementation and maintenance of quality procedures across the supply chain; Conduct internal, corporate, and supplier audits; Lead approval and maintenance of technical documentation and policies; Manage and develop the Quality Assurance team; Ensure product release and monitor lifecycle including pharmacovigilance and recalls; Serve as Technical Responsible Person before regulatory authorities; Manage critical suppliers and service providers; Lead governance of KPIs and executive reports; Play a strategic role in evaluating new products and business risks
Seniority
Senior, hands-on IC with strategic oversight
