Quality Assurance Manager (Pharmaceutical)

Job Description

The Quality Assurance (QA) Manager is responsible for ensuring all Quality and GMP-related activities supporting operations between the United States and Latin America are executed in compliance with FDA regulations, GMP standards, ISO requirements, and the Company’s Quality Management System (QMS). This role oversees GMP-compliant services, medicinal products, samples, and kits supporting international operations, ensuring regulatory compliance, operational consistency, and high-quality service delivery across the USA and LATAM regions. Key Responsibilities Quality & Compliance Maintain and improve the Quality Management System (QMS) in compliance with: GMP, FDA regulations (21 CFR), ISO 9001 / ISO 13485, ICH Q10, GDP standards Serve as the primary Quality and GMP contact for U.S. operations. Ensure compliance with corporate quality policies and data integrity standards (ALCOA ). Monitor regulatory changes and implement updates as needed. Audits & Inspections Lead internal audits and self-inspections. Host customer, FDA, and ISO audits and inspections. Manage audit readiness, corrective actions, and follow-up activities. Quality Operations Manage: Deviations, Non-conformances, CAPA programs, Root cause investigations, Change control, Document control, Training records Ensure compliance for product complaints, recalls, and quality events. Oversee calibration and preventive maintenance programs. Training & Cross-Functional Support Ensure employees receive GMP and quality compliance training. Collaborate with Operations, Distribution, Purchasing, Finance, and Customer Service teams to support compliant operations.