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:

We are seeking a Quality Compliance Consultant with a strong background in quality management, regulatory compliance, and training within the pharmaceutical industry, and experience interacting with stringent regulatory authorities (SwissMedic, FDA, EMA). The role involves developing comprehensive training programs, ensuring compliance with regulatory requirements, and preparing the business for audits and inspections. The ideal candidate will have a proven track record in quality management systems, regulatory compliance, and training delivery within the pharmaceutical industry.

Requirements:

• Bachelor’s or Master’s degree in Life Sciences, Quality Management, or a related field.
• Minimum 5-7 years of experience in quality management, regulatory affairs, or training within the pharmaceutical industry.
• In-depth knowledge of SRA Quality regulations (FDA, EMA or SwissMedic) and GDP requirements, ideally through significant work with or for a Swiss based pharma company or biotech.
• Proven experience in designing and delivering training programs for regulatory compliance.
• Strong understanding of ISO 9001, ISO 13485, or other quality management systems.
• Excellent communication, presentation, and stakeholder engagement skills.
• Ability to simplify complex regulatory topics into engaging and accessible training materials.
• Experience preparing for regulatory audits and inspections

• Audit Preparation & Execution - Support internal and external consulting teams in the review of internal documentation, assessment of current processes, and advise on readiness plans to meet regulatory requirements. Recommend and track corrective and preventive actions (CAPAs) based on audit findings.
• SOP Development - Ensure SOPs reflect relevant quality regulations (WHO, EMA, Swiss, FDA) Good Distribution Practice (GDP) standards, and business needs.
• Quality Management System monitoring - Evaluate the existing QMS and recommend improvements to align to relevant industry standards an collaborate with stakeholders to implement best practices that foster a culture of compliance and quality excellence.
• Regulatory Guidance - Provide ongoing coaching and advisory support on regulatory best practices and quality systems.
• Universal Health Coverage Integration - Support the integration of new medicines into Universal Health Coverage frameworks through strategic collaboration with national payers in LMICs.
• Training and Development - Collaborate with internal stakeholders to assess training needs, design tailored modules on Good Distribution Practice (GDP) and quality management systems, deliver workshops to ensure regulatory understanding, and implement a validation system to document compliance.
• Cross-Functional Collaboration - Work closely with Commercial, Tech, Legal and Regulatory teams to align training programs with business objectives.
• Knowledge Transfer - Conduct affordability and health economics research to support the inclusion of medicines into the WHO Essential Medicines List.
• Continuous Improvement - Stay current with evolving regulatory guidelines and recommend improvements to training programs and quality management systems based on feedback and regulatory updates.

Requirements:

• Bachelor’s or Master’s degree in Life Sciences, Quality Management, or a related field.
• Minimum 5-7 years of experience in quality management, regulatory affairs, or training within the pharmaceutical industry.
• In-depth knowledge of SRA Quality regulations (FDA, EMA or SwissMedic) and GDP requirements, ideally through significant work with or for a Swiss based pharma company or biotech.
• Proven experience in designing and delivering training programs for regulatory compliance.
• Strong understanding of ISO 9001, ISO 13485, or other quality management systems.
• Excellent communication, presentation, and stakeholder engagement skills.
• Ability to simplify complex regulatory topics into engaging and accessible training materials.

• Experience preparing for regulatory audits and inspections.