QMS Lead

About Axmed

Axmed is a pioneering platform transforming the procurement of medicines and healthcare products across low- and middle-income countries (LMICs). With a unique demand-aggregation model, Axmed connects healthcare providers, governments, NGOs, and pharmaceutical manufacturers to provide affordable, high-quality medicines regardless of geography or income. Founded in 2023 with 57 employees, the company aims to make medicines more accessible and to strengthen purchasing power in emerging markets through partnerships with authorized pharmaceutical companies and certified caregivers.

Role Overview

The QMS Lead plays a critical hands-on role in the daily execution of quality assurance and control processes. This includes conducting supplier and product quality audits, maintaining and improving the Quality Management System (QMS), managing corrective and preventive actions (CAPAs), overseeing compliance with GDP and GMP standards, and ensuring preparedness for regulatory and customer audits. The position interfaces closely with multiple teams—Commercial, Operations, Technology, Legal, and Regulatory—to embed quality processes in a lean, remote-first environment. Reporting will be to the Head of Quality once appointed.

Key Responsibilities

• Coordinate day-to-day quality assurance activities such as supplier and product inspections, documentation reviews, consignment release, and handling non-conformance issues, adhering to Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) guidelines.
• Support preparation for and execution of internal and external audits and inspections by assessing processes against regulatory standards, preparing required documentation, and managing CAPAs until resolution.
• Develop and update Standard Operating Procedures (SOPs) aligned with WHO MQAS and GDP standards tailored to organizational workflows.
• Continuously evaluate and improve the QMS to align with industry standards and operational needs in collaboration with various stakeholders.
• Qualify suppliers and logistics partners by collecting documentation, conducting risk assessments, and performing supplier audits.
• Design and deliver training on GDP and quality systems for internal teams while maintaining compliance records.
• Provide ongoing, clear regulatory and quality support and guidance to cross-functional teams and keep abreast of evolving regulatory requirements.

Required Skills and Experience

• Demonstrated hands-on experience applying GDP and GMP principles within pharmaceutical, medical device, or health supply chain environments, especially with WHO MQAS framework.
• Familiarity with stringent regulatory quality requirements from authorities like FDA, EMA, or Swissmedic and WHO guidance applicable to distribution and procurement.
• Expertise in SOP drafting, document control, deviation and CAPA management, along with maintenance of QMS systems such as ISO 9001 or ISO 13485.
• Proficiency with digital and AI tools relevant to quality management and audit processes.
• Skilled in planning and executing internal and supplier audits, as well as supporting regulatory and customer inspections.
• Strong communication capabilities to simplify complex regulatory information and provide effective training.
• 4 to 7 years of relevant quality assurance/control experience with practical involvement in audits, quality checks, and compliance activities.
• Experience functioning in lean teams or startups, often with limited internal resources, and preparing for regulatory audits.
• Exposure to humanitarian or global health supply chains or experience with European or Swiss pharmaceutical distributors is advantageous.

Desired Personal Attributes

• Self-motivated and highly organized, capable of managing quality activities independently.
• Pragmatic, risk-based thinker with a keen eye for critical details.
• Collaborative and approachable in fostering a supportive quality culture rather than one based on enforcement.
• Adaptable to remote, asynchronous workflows across multiple time zones.
• Digitally agile, with a preference for digital-first methods.

Additional Information

Applicants must already hold legal authorization to work in their residing country as the company cannot provide visa sponsorship or relocation assistance.

Benefits

• Unlimited paid time off for maintaining a healthy work-life balance.
• Monthly wellness allowance to support personal health.
• Paid parental leave to support family bonding.
• Flexible working hours for lifestyle adaptability.
• Annual company retreats to foster team connection and culture.
• Fully remote work option allowing location independence.
• Opportunity to contribute to a mission-driven company focused on healthcare equity.
• Competitive salary package aligned with experience and skills.
• Strong potential for career growth and professional development.