Quality Assurance Manager (Pharmaceutical)

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 Companys 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.

Supply Chain & Distribution

• Ensure compliant distribution of medicines samples and kits between the United States and Latin America.
• Support GDP compliance product traceability and supply chain security.
• Maintain Business Continuity and Security Management programs.

Reporting & Continuous Improvement

• Track and report quality KPIs and metrics.
• Drive continuous improvement initiatives across operations and quality systems.

Qualifications

• Bachelors degree in Life Sciences Engineering Pharmacy or related field required.
• Masters degree or certifications such as ASQ CQE or Lean Six Sigma preferred.
• 5 years of Quality Assurance or Quality Systems experience in a GMP-regulated environment.
• Experience with FDA GMP ISO 9001/13485 GDP and ICH Q10 regulations.
• Experience supporting international operations or cross-border supply chains between USA and LATAM preferred.
• Pharmaceutical biotech medical device or clinical trial logistics experience preferred.
• Strong knowledge of GMP FDA ISO and Quality Systems.
• Experience with CAPA audits investigations and risk management.
• Strong leadership communication and problem-solving skills.
• Proficient in Microsoft Office QMS platforms and quality tools.
• Bilingual English/Spanish preferred.

Reporting Structure

Reports directly to the Regional Quality Manager EMEA / USA / APAC.