QMS Lead at Axmed

About the Position:

• Axmed is building a B2B marketplace that changes how quality medicines are procured across low and middle income countries (LMICs), alongside logistics SaaS and trade financing that connect healthcare providers, governments, NGOs and pharmaceutical manufacturers through one data-driven platform. Quality is the promise that makes the marketplace work: buyers need to trust every product and every supplier on it.

• As Quality Lead you are the hands-on owner of day-to-day quality assurance and quality control operations. You will run external audits and quality checks in the system to prevent issues, maintain and improve the Quality Management System (QMS), write and update SOPs, manage CAPAs, qualify suppliers and products, and keep Axmed ready for regulatory and customer audits. You will work closely with Commercial, Operations, Tech, Legal and Regulatory colleagues to make quality practical for a lean, remote-first team, and you will report to the Head of Quality once that role is filled.

What you'll own

• Run quality assurance day to day: 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: prepare documentation, assess current processes against requirements, advise on readiness plans, and recommend and track corrective and preventive actions (CAPAs) through to closure.

• Develop and maintain SOPs so they reflect WHO MQAS and Good Distribution Practice (GDP) standards and how Axmed works.

• Monitor and improve the QMS: evaluate the existing system, recommend improvements aligned to industry standards, and work with stakeholders to implement them.

• Qualify and monitor suppliers and logistics partners: collect and review quality documentation, run risk assessments and support supplier audits.

• Design and deliver training on GDP and quality systems at axmed for internal teams, and maintain the records that demonstrate compliance.

• Provide ongoing, practical regulatory and quality guidance to Commercial, Tech, Legal and Regulatory colleagues, and stay current with evolving guidance so processes keep pace.

Skills:

• Hands-on application of GDP and GMP in a pharmaceutical, medical device or health supply chain setting. Particular focus to WHO MQAS framework.

• Working knowledge of stringent regulatory authority quality requirements (FDA, EMA or Swissmedic) and WHO guidance, and how they apply to distribution and procurement.

• SOP writing, document control, deviation and CAPA management, and QMS maintenance (ISO 9001, ISO 13485 or equivalent).

• Strong and consistent digital and AI exposure

• Audit preparation and execution: internal audits, supplier audits and supporting regulatory or customer inspections.

• Clear written and verbal communication; able to simplify complex regulatory topics into accessible guidance and training.

Experience

• 4 to 7 years in quality assurance or quality control, ideally within pharma, medical devices or health supply chain.

• Demonstrated hands-on execution: audits, quality checks, documentation, GDP or GMP application, rather than oversight only.

• Experience operating with limited internal infrastructure, for example in a lean team, a startup or a 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.

Traits

• Self-starting and organised: comfortable owning a quality workload end to end without a large team around them.

• Pragmatic and risk-based, with high attention to detail where it matters.

• Collaborative and approachable; makes quality feel like support rather than policing.

• Adaptable to remote, asynchronous working across time zones.

• Digital first