Quality Assurance Manager (Pharmaceutical)

OCASA Life Sciences

Required skills

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.

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.

Ensure employees receive GMP and quality compliance training.
Collaborate with Operations, Distribution, Purchasing, Finance, and Customer Service teams to support compliant operations.

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.

Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related field required.
Master’s 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.

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

Specialized global logistics provider for life sciences and pharmaceuticals.

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