Head of Quality & Compliance

• Define and continuously improve the global Quality Management System aligned with GMP/GDP and WHO MQAS standards.
• Manage daily quality assurance activities within the Axmed platform, including product qualification and validation.
• Lead the integration of AI and data-driven tools to automate quality checks and enhance monitoring.
• Build and lead the Quality team, setting objectives and fostering expertise in AI-assisted quality processes.
• Oversee internal and external audit programmes, including supplier GMP/GDP audits and regulatory inspections.
• Maintain the company-wide risk register and report on risk exposure and mitigation.
• Manage deviation handling, CAPA programmes, and product recalls with full traceability and rapid execution.

• At least 10 years of quality assurance experience in pharmaceutical or medical device supply chains or manufacturing, including multi-country operations.
• Proven leadership in building or heading a quality function, preferably at Head or Director level.
• Strong knowledge of GMP/GDP, WHO MQAS, and familiarity with stringent regulatory authorities like EMA, Swissmedic, and FDA.
• Experience with electronic Quality Management Systems (eQMS), including documentation and SOP management.
• Capability to lead external GMP/GDP audits and internal audit programmes, with success in regulatory inspections.
• Skilled in applying AI and data tools to quality processes, with prior deployment experience preferred.
• Ability to simplify regulations into practical processes for non-quality staff.
• Experience managing QC testing programmes in pharma or med tech.
• Experience in emerging markets and multi-country regulatory compliance.
• Experience reporting to executive leadership and managing teams.
• A Bachelor of Pharmacy, Pharm.D., or equivalent pharmacy degree.
• Legal right to work in the country of residence, as visa sponsorship is not offered.

The role offers competitive salaries, unlimited paid time off, a monthly wellness allowance, paid parental leave, flexible working hours, fully remote work, annual off-site retreats, and opportunities for professional growth.

The employer has not published a closing date.