Quality Management System (QMS) Lead – Remote

About the role

Axmed is building a B2B marketplace that transforms how quality medicines are procured across low‑ and middle‑income countries. As the QMS Lead you will own day‑to‑day quality assurance and control, ensuring the platform meets stringent regulatory standards while supporting a remote‑first team.

Key responsibilities

• Conduct supplier and product quality checks, manage consignment releases and handle non‑conformances following GDP and GMP principles.
• Prepare and support internal and external audits, create readiness plans and track corrective and preventive actions (CAPAs) to closure.
• Develop, maintain and update SOPs aligned with WHO MQAS and Good Distribution Practice standards.
• Evaluate and improve the Quality Management System, recommending enhancements based on ISO 9001/13485 frameworks.
• Qualify and monitor suppliers and logistics partners through risk assessments and documentation reviews.
• Design and deliver GDP and quality system training for internal teams and maintain compliance records.

Required profile

• 4‑7 years of hands‑on quality assurance or control experience in pharma, medical devices or health supply chains.
• Proven ability to execute audits, manage CAPAs and work in lean, remote environments.
• Experience preparing for regulatory inspections (FDA, EMA, Swissmedic) and familiarity with humanitarian or global‑health supply chains is a plus.
• Self‑starting, detail‑oriented and collaborative mindset with strong risk‑based decision making.

Required skills

• Hands‑on application of GDP and GMP, especially within the WHO MQAS framework.
• Knowledge of FDA, EMA and Swissmedic regulatory requirements.
• SOP writing, document control and CAPA management.
• QMS maintenance experience (ISO 9001, ISO 13485 or equivalent).
• Exposure to digital and AI tools for quality monitoring.
• Audit preparation and execution for internal, supplier and regulatory inspections.

What we offer

• Unlimited PTO and monthly wellness allowance.
• Paid parental leave and flexible working hours.
• Fully remote work with annual off‑site retreats.
• Competitive salary and clear growth opportunities.
• Mission‑driven environment focused on improving healthcare equity.