Quality Management System Lead (QMS)

About the role

Axmed is building a B2B marketplace for quality medicines across low and middle income countries, together with logistics SaaS and trade financing. As Quality Lead you are the hands-on owner of day-to-day quality assurance and quality control operations, working with Commercial, Operations, Tech, Legal and Regulatory colleagues in a lean, remote-first team and reporting to the Head of Quality once that role is filled.

Key responsibilities

• Run quality assurance daily: supplier and product quality checks, documentation review, consignment release and non-conformance handling in line with GDP and GMP principles.
• Support internal and external audits and inspections by preparing documentation, assessing processes against requirements, advising on readiness plans and tracking CAPAs through to closure.
• Develop and maintain SOPs reflecting WHO MQAS and GDP standards.
• Monitor and improve the QMS, recommending improvements aligned to industry standards.
• Qualify and monitor suppliers and logistics partners, including risk assessments and supplier audit support.
• Design and deliver GDP and quality system training, and keep compliance records.
• Provide practical regulatory and quality guidance to colleagues and stay current with evolving guidance.

Required profile

• 4 to 7 years in quality assurance or quality control, ideally in pharma, medical devices or health supply chain.
• Demonstrated hands-on execution of audits, quality checks and documentation, rather than oversight only.
• Experience operating with limited internal infrastructure, such as in a lean team, startup or field-based supply chain role.
• Experience preparing for regulatory audits and inspections.
• Exposure to humanitarian or global health supply chain organisations, or to a Swiss or European pharma distributor, is a strong plus; experience designing and delivering compliance training is also valued.

Required skills

• Hands-on application of GDP and GMP, with particular focus on the WHO MQAS framework.
• Working knowledge of FDA, EMA or Swissmedic quality requirements and WHO guidance.
• SOP writing, document control, deviation and CAPA management, and QMS maintenance (ISO 9001, ISO 13485 or equivalent).
• Strong and consistent digital and AI exposure.
• Clear written and verbal communication, able to simplify complex regulatory topics.