QMS Lead – Quality Assurance & Control

About the role

Axmed is building a B2B marketplace that transforms access to medicines in low‑ and middle‑income countries. As the QMS Lead you will own day‑to‑day quality assurance and control, ensuring that every product and supplier meets the highest standards of safety and compliance.

Key responsibilities

• Conduct supplier and product quality checks, review documentation, release consignments and manage non‑conformances in line with GDP and GMP principles.
• Support internal and external audits by preparing documentation, assessing processes, advising on readiness, and tracking corrective and preventive actions (CAPAs) to closure.
• Develop, maintain and update SOPs to reflect WHO MQAS and Good Distribution Practice (GDP) standards and the way Axmed operates.
• Evaluate and improve the Quality Management System (QMS), recommending enhancements aligned with industry standards.
• Qualify and monitor suppliers and logistics partners through risk assessments, documentation review and audit support.
• Design and deliver GDP and quality‑system training for internal teams and keep compliance records up to date.
• Provide practical regulatory and quality guidance to Commercial, Tech, Legal and Regulatory colleagues, staying current with evolving guidance.

Required profile

• Hands‑on experience applying GDP and GMP in a pharmaceutical, medical‑device or health‑supply‑chain environment.
• Familiarity with WHO MQAS framework and stringent regulatory requirements (FDA, EMA or Swissmedic).
• Proven ability to manage audits, CAPAs and supplier qualification processes.
• Strong documentation skills and ability to create clear, compliant SOPs.

Required skills

• Good Distribution Practice (GDP)
• Good Manufacturing Practice (GMP)
• WHO MQAS framework
• FDA regulatory requirements
• EMA regulatory requirements
• Swissmedic regulatory requirements
• Quality Management System (QMS) implementation