Director of Quality Assurance

Job Summary

This global role oversees Quality Assurance (QA) for GMP activities across drug substance, product, and packaging operations, covering both owned and contracted manufacturing sites. The role is key in leading regulatory inspection readiness, execution, support, and remediation, maintaining compliance and fostering productive relationships with internal and external stakeholders.

Responsibilities

• Lead inspection readiness, including mock inspections and on-site regulatory support; manage GMP evaluations for the global supply chain.
• Ensure regulatory compliance for manufacturing operations globally, liaising with regulatory agencies.
• Contribute to global QA strategies and drive quality improvement initiatives with external suppliers.
• Collaborate with cross-functional teams to ensure GMP quality and compliance, including vendor selection and CAPA management.
• Stay updated on cGMP regulations, train staff, and develop a culture of quality and integrity.
• Lead risk management, remediation activities, and continuous improvement to enhance the organization's Quality Management System.

Qualifications

• Bachelor's Degree required; Master's Degree preferred.
• 10+ years in QA management or regulatory authority with demonstrated success.
• 7+ years managing quality in a regulated global healthcare setting.
• Strong experience in pharmaceuticals, medical devices, or related fields, including direct interactions with global health authorities.
• Expertise in continuous improvement, change management, and quality management principles.

Travel

• Up to 50% travel, including international.