QMS Lead

Embodied AI; Basel; Hybrid; CHF 120.000 - 190.000; Vollzeit

Benefits dieser Stelle

Unlimited PTO

Monthly wellness allowance

Paid parental leave

Flexible working hours

Annual off-site retreats

Fully remote work

Opportunity to make a difference

Competitive salaries

Room for growth

Zusammenfassung

Embodied AI is seeking a Quality Lead to own day-to-day QA/QC operations, perform external audits, and maintain the Quality Management System. You will collaborate with Commercial, Operations, Tech and Regulatory teams to ensure compliance across GDP, GMP and WHO MQAS standards.

You will drive supplier qualification, CAPA management, SOP development, and training programs while supporting regulatory audits and inspections in a fully remote, lean, global team.

Qualifikationen

• Hands-on GDP and GMP experience in pharma/medical devices or health supply chain.
• Knowledge of FDA/EMA/Swissmedic and WHO guidance for distribution and procurement.
• SOP writing, document control, deviation and CAPA management, and QMS maintenance (ISO 9001/13485).
• Strong and consistent digital and AI exposure.
• Audit preparation and execution: internal audits, supplier audits and supporting regulatory or customer inspections.
• Clear written and verbal communication; ability to simplify regulatory topics into accessible guidance and training.

Aufgaben

• Run quality assurance day to day: supplier and product quality checks, documentation review, consignment release and non-conformance handling in line with GDP and GMP principles.
• Support internal and external audits and inspections: prepare documentation, assess current processes against requirements, advise on readiness plans, and track CAPAs through to closure.
• Develop and maintain SOPs reflecting WHO MQAS and GDP standards and how Axmed works.
• Monitor and improve the QMS: evaluate the existing system, implement industry-aligned improvements.
• Qualify and monitor suppliers and logistics partners: review quality docs, perform risk assessments, support supplier audits.
• Design and deliver GDP and quality systems training for internal teams, and maintain compliance records.
• Provide ongoing regulatory/quality guidance across Commercial, Tech, Legal and Regulatory teams, staying current with evolving guidance.

Kenntnisse

GDP/GMP application

Regulatory knowledge (FDA/EMA/Swissmed

Jobbeschreibung

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. Quality is the promise that makes the marketplace work: buyers need to trust every product and every supplier on it.

As Quality Lead you are the hands-on owner of day-to-day quality assurance and quality control operations. You will run external audits and quality checks in the system to prevent issues, maintain and improve the Quality Management System (QMS), write and update SOPs, manage CAPAs, qualify suppliers and products, and keep Axmed ready for regulatory and customer audits. You will work closely with Commercial, Operations, Tech, Legal and Regulatory colleagues to make quality practical for a lean, remote-first team, and you will report to the Head of Quality once that role is filled.

What you’ll own

• Run quality assurance day to day: supplier and product quality checks, documentation review, consignment release and non-conformance handling in line with GDP and GMP principles.
• Support internal and external audits and inspections: prepare documentation, assess current processes against requirements, advise on readiness plans, and recommend and track corrective and preventive actions (CAPAs) through to closure.
• Develop and maintain SOPs so they reflect WHO MQAS and Good Distribution Practice (GDP) standards and how Axmed works.
• Monitor and improve the QMS: evaluate the existing system, recommend improvements aligned to industry standards, and work with stakeholders to implement them.
• Qualify and monitor suppliers and logistics partners: collect and review quality documentation, run risk assessments and support supplier audits.
• Design and deliver training on GDP and quality systems at axmed for internal teams, and maintain the records that demonstrate compliance.
• Provide ongoing, practical regulatory and quality guidance to Commercial, Tech, Legal and Regulatory colleagues, and stay current with evolving guidance so processes keep pace.

Skills

• Hands-on application of GDP and GMP in a pharmaceutical, medical device or health supply chain setting. Particular focus to WHO MQAS framework.
• Working knowledge of stringent regulatory authority quality requirements (FDA, EMA or Swissmedic) and WHO guidance, and how they apply to distribution and procurement.
• SOP writing, document control, deviation and CAPA management, and QMS maintenance (ISO 9001, ISO 13485 or equivalent).
• Strong and consistent digital and AI exposure.
• Audit preparation and execution: internal audits, supplier audits and supporting regulatory or customer inspections.
• Clear written and verbal communication; able to simplify complex regulatory topics into accessible guidance and training.

Experience

• 4 to 7 years in quality assurance or quality control, ideally within pharma, medical devices or health supply chain.
• Demonstrated hands-on execution: audits, quality checks, documentation, GDP or GMP application, rather than oversight only.
• Experience operating with limited internal infrastructure, for example in a lean team, a startup or a field-based supply chain role.
• Experience preparing for regulatory audits and inspections.
• Exposure to humanitarian or global health supply chain organisations, or to a Swiss or European pharma distributor, is a strong plus. Experience designing and delivering compliance training is also valued.

Traits

• Self-starting and organised: comfortable owning a quality workload end to end without a large team around them.
• Pragmatic and risk-based, with high attention to detail where it matters.
• Collaborative and approachable; makes quality feel like support rather than policing.
• Adaptable to remote, asynchronous working across time zones.
• Digital first.

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?

• 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.