Quality Compliance Consultant at Axmed

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.

Key Responsibilities:

• 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.