Global Quality Lead for Medicines Access

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

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.