Global Quality Leader & Strategy Architect

ProSciento, Inc.; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

ProSciento, Inc. seeks a Global Head of Quality to lead the Quality department, drive QMS governance, and ensure regulatory compliance across GxP, FDA, ISO, and regional standards. The role oversees quality systems, CAPA processes, inspections, and quality by design while aligning with corporate strategy and global operations.

The position requires extensive leadership experience, strategic vision, and the ability to manage a global quality organization with travel expectations.

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 10+ years in Quality Assurance or Regulatory Compliance with CRO/clinical research exposure.
• 5+ years in senior quality leadership with global responsibility.

Responsibilities

• Provide strategic leadership for the Quality department and set priorities.
• Oversee QMS design, implementation, and continuous improvement for GxP compliance.
• Lead regulatory inspections, audits, CAPA governance, and inspection readiness.

Skills

Quality governance

GxP compliance

Regulatory inspections

Quality management systems

Leadership

Strategic planning

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

eQMS

Document management systems

Job description

ProSciento, Inc. seeks a Global Head of Quality to lead the Quality department, drive QMS governance, and ensure regulatory compliance across GxP, FDA, ISO, and regional standards. The role oversees quality systems, CAPA processes, inspections, and quality by design while aligning with corporate strategy and global operations.

The position requires extensive leadership experience, strategic vision, and the ability to manage a global quality organization with travel expectations.