Global Head of Quality & Compliance | AI-Driven eQMS

OpenKrill; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Axmed is seeking a seasoned Quality Leader to own the global QMS strategy across multiple jurisdictions. You will drive regulatory alignment, lead internal and external audits, and oversee CAPA and recalls with robust data- driven processes.

You will build an AI-enabled, automated QA framework, mentor teams across time zones, and ensure product safety and compliance in emerging markets. Strong collaboration with Regulatory Affairs and Commercial is essential.

Qualifications

• Experience with GMP/GDP systems and WHO MQAS expectations.
• Proven track record building/evolving an electronic QMS (eQMS).
• Leadership of external GMP/GDP audits and inspections.

Responsibilities

• Define and lead the global QMS strategy across jurisdictions.
• Own audits, CAPA and recalls with end-to-end traceability.
• Lead AI-assisted quality controls and automated review processes.

Skills

GMP/GDP adherence

eQMS ownership

Audit leadership

AI/data in QA

Regulatory interpretation

Quality program governance

Education

Pharmacy degree

Job description

Axmed is seeking a seasoned Quality Leader to own the global QMS strategy across multiple jurisdictions. You will drive regulatory alignment, lead internal and external audits, and oversee CAPA and recalls with robust data- driven processes.

You will build an AI-enabled, automated QA framework, mentor teams across time zones, and ensure product safety and compliance in emerging markets. Strong collaboration with Regulatory Affairs and Commercial is essential.