QHSE Healthcare Expert

The purpose of this role is to lead and strengthen the Healthcare Quality Management System across NORTAM by ensuring compliance with applicable regulatory, customer, ISO, GDP/GMP, and internal QMS requirements. The position supports healthcare operations in maintaining product integrity, audit readiness, effective CAPA management, controlled documentation, training compliance, supplier management and continuous improvement to enable safe, compliant, and reliable healthcare logistics services across all the products managed (Air, Ground, Ocean &CL).

Maintain healthcare-controlled documentation and management practice records in alignment with regional and global requirements.

• Maintain and continuously improve the Healthcare QMS, ensuring alignment with global, regional, regulatory, and customer requirements.
• Provide quality leadership and technical guidance to healthcare operations, account management, business development, and site teams.
• Ensure healthcare-controlled documentation, SOPs, work instructions, records, and management practice records are current, controlled, and effectively implemented.
• Coordinate audit readiness activities, including internal audits, customer audits, supplier audits, regulatory inspections, and follow-up actions.
• Lead or support investigations, nonconformance management, root cause analysis, CAPA implementation, and effectiveness verification.
• Support product integrity controls, including temperature‑controlled storage, handling, transportation, returns, recalls, and risk mitigation activities.
• Monitor quality metrics, customer feedback, CAPA trends, audit results, training compliance, and site deliverables to identify improvement opportunities.
• Support supplier qualification, supplier performance monitoring, and healthcare‑specific supplier quality requirements.
• Promote a culture of compliance, patient safety, right‑first‑time execution, accountability, and continuous improvement across healthcare operations.

• Maintain the Healthcare QMS and associated documentation.
• Ensure compliance with applicable regulatory, customer, and quality requirements.
• Support licensing and regulatory compliance activities.
• Monitor regulatory changes and communicate impacts to healthcare operations and leadership.
• Assist sites in maintaining audit and inspection readiness.

• Coordinate internal, customer, supplier, and regulatory audits.
• Lead investigations of quality issues and nonconformances.
• Manage Corrective and Preventive Actions (CAPA) and verify effectiveness.

• Support the safe storage, handling, and distribution of healthcare products.
• Monitor quality controls affecting product integrity, including temperature‑controlled processes.
• Participate in risk assessments and mitigation activities.

• Identify quality‑related training requirements.
• Support training matrix management and employee competency programs.
• Verify completion and effectiveness of required training.

• Act as a quality contact for healthcare customers and operations teams.
• Support implementation of customer requirements, SOPs, and operational changes.
• Participate in quality reviews and customer meetings.
• Analyze quality metrics and trends.
• Drive initiatives to improve compliance, efficiency, and customer satisfaction.
• Promote a culture of quality and continuous improvement.

• Bachelor’s degree in quality, Life Sciences, Pharmacy, Engineering, Supply Chain, Healthcare, Logistics, or a related field required; advanced degree preferred.
• Minimum 7 years of experience in healthcare quality, pharmaceutical, medical device, life sciences, regulated logistics, or related quality management environments preferred.
• Demonstrated experience supporting or leading QMS implementation, audits, CAPA, training compliance, supplier qualification, and customer quality requirements.
• Knowledge of ISO 9001, ISO 13485, GDP, GMP, regulatory expectations, and healthcare logistics compliance requirements.
• Internal Auditor or Lead Auditor certification preferred.
• Experience in multi‑site, regional, or cross‑functional…