QMS Lead

Company Vision & Mission

We are committed to ensuring access to medicines and healthcare for all people across low and middle income countries (LMICs), regardless of their geographical or economic status. Our goal is to accelerate the availability of essential medicines worldwide.

About Axmed

Axmed is innovating a B2B marketplace that revolutionizes how quality medicines are sourced in LMICs. Our platform integrates logistics software and trade financing solutions, connecting healthcare providers, governments, NGOs, and pharmaceutical producers in a single data-driven environment. Upholding quality is paramount as it underpins trust in every product and supplier featured.

Position Overview

As the Quality Lead, you will directly manage daily quality assurance and control functions. Responsibilities include conducting external audits, monitoring quality within the system to avert issues, enhancing the Quality Management System (QMS), authoring and updating SOP documentation, managing CAPA processes, qualifying suppliers and products, and maintaining readiness for regulatory and customer audits. Collaboration with teams across Commercial, Operations, Technology, Legal, and Regulatory departments is essential to adapt quality practices for a lean, fully remote team structure. You will report to the Head of Quality once that position is established.

Primary Duties

• Execute daily quality assurance tasks such as supplier and product verifications, reviewing documentation, consignment releases, and managing non-conformances aligned with GDP and GMP standards.
• Facilitate preparation for internal and external audits including documentation assembly, evaluating current procedures against audit criteria, advising on audit readiness, and overseeing corrective and preventive action (CAPA) tracking through resolution.
• Create and maintain SOPs that comply with WHO MQAS and GDP standards, reflecting how Axmed operates.
• Assess and enhance the QMS by evaluating current systems, proposing improvements consistent with industry benchmarks, and coordinating with stakeholders to implement updates.
• Conduct risk assessments and audits to qualify and monitor suppliers and logistics partners by reviewing quality documentation.
• Develop and deliver GDP and quality system training to internal teams while maintaining compliance documentation.
• Provide continuous practical guidance regarding regulatory and quality matters to cross-functional colleagues, staying abreast of evolving standards to keep processes current.

Required Skills & Experience

• Practical experience implementing GDP and GMP standards within pharmaceutical, medical device, or health supply chain contexts, with emphasis on the WHO MQAS framework.
• Knowledgeable in quality standards required by stringent regulatory authorities such as FDA, EMA, or Swissmedic, and WHO guidelines related to procurement and distribution.
• Competency in SOP development, document control, deviation and CAPA management, and QMS upkeep compliant with ISO 9001, ISO 13485, or equivalent benchmarks.
• Comfortable using digital tools and AI technologies for quality operations.
• Experience leading audits internally, at suppliers, and supporting regulatory or customer inspections.
• Excellent verbal and written communication skills; able to translate complex regulatory concepts into clear, accessible instructions and training.

• 4 to 7 years of hands-on quality assurance or control experience within pharmaceutical, medical device, or health supply chains.
• Proven practical involvement in audits, quality verifications, documentation processes, and application of GDP or GMP standards rather than purely supervisory roles.
• Familiarity operating in lean or startup environments with limited infrastructure, and experience prepping for regulatory audits and inspections.
• Experience with humanitarian or global health supply chain organizations, or Swiss/European pharmaceutical distributors is a plus, as is experience designing and providing compliance training.

Personal Attributes

• Self-motivated and well-organized, capable of independently managing end-to-end quality responsibilities without a large supporting team.
• Pragmatic, risk-focused, and sharply attentive to detail where it is most critical.
• Collaborative and approachable, fostering a supportive rather than punitive quality environment.
• Adapts well to remote and asynchronous work models across different time zones.
• Digitally savvy with strong affinity for technology-driven approaches.

Additional Information

Right to Work: Candidates must already hold the legal right to work in their residing country as the company currently does not provide visa sponsorship or relocation assistance.

Benefits

• Unlimited paid time off to support work-life balance.
• Monthly wellness allowance to prioritize health and wellbeing.
• Paid parental leave to support family bonding without added stress.
• Flexible working hours enabling tailored workday arrangements.
• Annual offsite retreats for team bonding and relationship building.
• Fully remote work opportunity with a globally distributed team.