Head of Quality & Compliance

Job description

Our Vision We believe in a world where everyone, regardless of their country’s wealth or frontiers, enjoys access to medicines and healthcare when they need it. Our Mission We work tirelessly to remove access barriers faced by patients and caregivers across Low and Middle-Income Countries (LMICs) when seeking quality medicines and quality healthcare. Who We Are: Accelerating access to medicines for all Imagine a world where critical medicines are within reach, affordable, and synonymous with quality, no matter where you are. That is the world we're building with our unique, demand-aggregation model that unites healthcare providers across LMICs. At the heart of our identity is a single, resolute commitment: to build a future where geography and income never stand between any individual and life-saving medicines. Our platform isn't merely a space for transactions, we unlock affordable access to medicines by aggregating demand across healthcare providers. We also help manufacturers build a sustainable and reliable global access strategy. Our business focuses on low- and middle-income countries and strengthens the purchasing power of these markets to ensure the supply of cost-effective, high-quality medicines. We partner exclusively with authorized, high-quality pharmaceutical companies and certified caregivers to accelerate sustainable access to medicines. 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. Every product moving through that platform has to be safe, genuine and handled to the right standard. This role exists to make that a guarantee rather than an aspiration. Reporting to the Chief Operations Officer, you will own quality assurance strategy and execution across Axmed's marketplace operations. You will set the direction for the Quality Management System globally, hold ultimate accountability for compliance across every jurisdiction Axmed operates in, and represent Axmed's quality and compliance posture to regulators, clients and partners. The system you build is digital-first: controls embedded in platform workflows rather than static documents, routine checks automated, and AI and data applied so the team focuses on judgement and expertise. You will build and lead the Quality function as it scales, starting with the Quality Lead. What you'll own Own quality strategy and the QMS: define and continuously evolve Axmed's global Quality Assurance Programme and QMS strategy, aligned to GMP/GDP standards and WHO MQAS requirements in every jurisdiction Axmed operates in, designed digital-first with controls embedded in platform workflows. Spearhead the Axmed Platform eQMS: run in-platform daily quality assurance, including organisation and product qualification, validation and QA release, and keep evolving the eQMS to meet changing business and regulatory needs, prioritising automation of manual review steps. Pioneer AI and frontier practice in quality: set the vision for how AI and data are applied, including automated dossier and CoA screening, anomaly detection across supplier and batch data, AI-assisted document review and continuous rather than periodic monitoring. Pilot quickly, validate rigorously, and position Axmed as a reference for modern quality assurance in emerging markets. Lead and develop the Quality function: build and manage the team as it scales, set objectives, and grow an AI-literate function where people focus on judgement while routine checks are automated. Hold final accountability for audit governance: own and run the risk-based internal and external audit programme, using data signals to target audits in line with SOPs. Lead external inspections and supplier audits: act as lead for client and regulator inspections, and run GMP/GDP audits of Axmed's suppliers, including remote and hybrid approaches supported by platform data. Own enterprise-wide risk: maintain the company-level Risk Register, report exposure and mitigation status to the COO and ELT, and build leading indicators that surface emerging risk early. Govern CAPA, deviations and recalls at policy level: manage deviation and complaint handling, the CAPA programme and product recall management in line with SOPs, acting as ultimate Responsible Person for recalls where required, with end-to-end traceability that supports rapid, targeted recall execution. Own multi-jurisdiction compliance: ensure quality and compliance practices meet local regulatory requirements in each market of operation. Design and run the annual QC sampling programme: a risk-based model driven by supplier, product and market data rather than uniform coverage. Partner across Regulatory Affairs, Commercial and Technology: drive SOP adherence, continuous self-inspection and regular reviews of programme effectiveness, and co-own the product roadmap for quality features on the Axmed platform. Represent Quality in commercial and regulatory decisions: provide quality and compliance input at ELT level on new market entry, seller and manufacturer onboarding, and product decisions. Build a culture of quality: champion quality and compliance as a company-wide discipline, sponsoring training, coaching and continuous improvement across internal teams and marketplace sellers, including through digital learning. What we're looking for Skills Strong working knowledge of GMP/GDP and pharmaceutical or medical device procurement quality systems, particularly WHO MQAS, plus working command of stringent regulatory authority expectations (EMA, Swissmedic, FDA). Direct experience of prequalification, supplier qualification and product recall management. Experience owning and evolving a full electronic Quality Management System (eQMS), including documentation, SOPs and records. Audit leadership: running external GMP/GDP audits and internal audit programmes, with a track record of hosting and passing regulatory or client inspections. Fluent in applying data and AI to quality work: comfortable specifying automation and AI-assisted controls. Prior deployment of such tooling is a strong advantage. Ability to translate regulation into simple, usable processes and decisions that non-quality colleagues can follow. Experience 10+ years in quality assurance in supply chain or manufacturing in pharma and/or med tech, including operating at a global or multi-country level. Proven track record leading or building a quality function, not only executing within one. Prior Head or Director of Quality Assurance, or equivalent seniority, preferred. Experience running or coordinating QC testing programmes in pharma or med tech. Experience in emerging markets, and with multi-country supply chain and regulatory compliance. Experience managing people and reporting into an Executive Leadership Team or C-suite level function. Familiarity with the health procurement or global health supply chain sector (for example QUAMED, PFSCM, IDA Foundation, GDF, UNICEF, UNFPA or similar) is a strong plus. Practical experience using AI tools to improve quality or compliance workflows, with clear judgement on validation and on where human review must remain. A pharmacy degree (Bachelor of Pharmacy, Pharm.D. or an equivalent recognised qualification). Traits Strategic and pragmatic in equal measure: able to set a multi-year quality vision and also decide what "good enough for now" looks like in a growing company. Comfortable operating in a lean, remote-first startup environment with limited internal infrastructure and a team spread across time zones. Credible and calm in front of regulators, executives, clients and suppliers; influences without needing authority. Builder and innovator mindset: energised by creating structure where little exists, by developing people, and by using technology to do quality differently. Right to Work: As an early-stage company, we are not currently able to offer visa sponsorship or relocation support. For this reason, candidates must already have the legal right to work in the country where they are based. What is in it for you? At Axmed, we believe in creating a supportive and rewarding environment where our team can thrive. Here’s what we offer: Unlimited PTO : Take the time you need to recharge and maintain work-life balance. Monthly wellness allowance : Prioritize your health and well-being with extra support. Paid parental leave : Time off to bond with your new family member without any added stress. Flexible working hours : Enjoy the freedom to structure your workday in a way that suits your lifestyle. Annual off-site retreats : Connect with the team and build lasting relationships during our company retreats. Fully remote work : Work from anywhere in the world and join our distributed team. The opportunity to make a difference : Be part of a mission-driven company working to improve healthcare equity. Competitive salaries : We offer a compensation package that reflects your skills and experience. Plenty of room for growth : We believe in nurturing talent and offering opportunities for professional development and advancement.