QMS Lead

Role Overview

Axmed operates a data-driven B2B marketplace aimed at making essential medicines more accessible and trustworthy across low- and middle-income countries. We connect healthcare providers, governments, NGOs, and pharmaceutical manufacturers with procurement, logistics software, and trade financing, which means every product listed must meet rigorous quality expectations. As Quality Lead, you will be the person who makes that promise real on a daily basis, taking full ownership of quality assurance and quality control activities in a lean, remote-first environment.

Your work will span everything from reviewing supplier documentation and running audits to maintaining the Quality Management System that keeps Axmed aligned with GDP, GMP, and WHO MQAS standards. Because the company operates with a small team, you will be expected to work hands-on, communicate clearly across Commercial, Operations, Tech, Legal, and Regulatory functions, and help build quality processes that are practical rather than bureaucratic. This role reports to the Head of Quality once that position is filled; until then, you will be the primary quality authority driving readiness and compliance.

Key Responsibilities

• Own day-to-day quality assurance and quality control tasks: performing supplier and product quality checks, reviewing documentation, releasing consignments, and managing non-conformance events in line with GDP and GMP principles.
• Prepare for and support internal and external audits and inspections, including regulatory or customer reviews, by assessing existing processes against requirements, building readiness plans, and tracking corrective and preventive actions through to closure.
• Develop, update, and maintain SOPs so they reflect the realities of Axmed’s operations while meeting WHO MQAS and Good Distribution Practice expectations.
• Monitor and continuously improve the Quality Management System: identify gaps, propose practical changes aligned with ISO 9001, ISO 13485, or equivalent frameworks, and work with stakeholders to implement those improvements.
• Qualify and monitor suppliers and logistics partners by collecting and reviewing quality documentation, performing risk assessments, and supporting supplier audits where needed.
• Create and deliver training for internal teams on GDP, quality systems, and documentation practices, maintaining the training records that demonstrate compliance.
• Provide pragmatic regulatory and quality guidance to colleagues across Commercial, Tech, Legal, and Regulatory teams, and keep processes current as relevant WHO, FDA, EMA, and Swissmedic guidance evolves.

Requirements & Qualifications

• 4–7 years of hands-on experience in quality assurance or quality control, ideally in pharmaceutical, medical device, or health supply chain settings, with strong practical application of GDP and GMP — not just oversight experience.
• Working knowledge of stringent regulatory authority expectations (FDA, EMA, or Swissmedic) and WHO guidance, with particular comfort applying the WHO MQAS framework to distribution and procurement activities.
• Broad technical skills covering SOP writing, document control, deviation management, CAPA processes, and ongoing maintenance of a QMS based on ISO 9001, ISO 13485, or similar standards.
• Demonstrated ability to prepare for and execute internal audits, supplier audits, and regulatory or customer inspections, including producing clear audit findings and follow-up actions.
• Comfort working with limited internal infrastructure — for example, in a startup, lean team, or field-based supply chain role — where you must own the full quality workload independently while still being organised and reliable.
• Excellent written and verbal communication, with a talent for turning complex regulatory topics into simple, approachable guidance and effective training for non-specialists.
• Familiarity with humanitarian or global health supply chain organisations, or with a Swiss or European pharmaceutical distributor, is a strong plus, as is prior experience designing and delivering compliance training.
• A pragmatic, risk-based mindset with high attention to detail where it genuinely matters, plus adaptability to remote, asynchronous work across multiple time zones.
• Digital first attitude: you are comfortable using modern productivity tools and are open to applying AI-driven solutions to make quality work more efficient and consistent.