Director, Global Quality Assurance, GMP Compliance

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Requirements:

• Bachelor's Degree required; Master's Degree preferred.
• 5+ years of direct Health Authority experience desired.
• 10+ years professional experience at a management level.
• 7+ years managing quality in an international, regulated healthcare environment.
• Experience with biologics is a must.
• Proven expertise in risk management, continuous improvement, and change management.
• Experience working with global Health Authorities (FDA, EMA, etc.).
• Strong knowledge of manufacturing processes and laboratory operations.
• Solid understanding of quality management and cGMP/GLP requirements.

Responsibilities:

• Responsible for leading inspection readiness activities, including mock inspections and support during regulatory inspections.
• Executes evaluations of GMP readiness for manufacturing organizations, identifying and mitigating risks.
• Ensures compliance for internal and external organizations in local and global markets.
• Liaises with regulatory agencies on GMP QA issues.
• Leads participation in project teams and contributes to achieving global QA vision.
• Proactively supports QA programs and vendor selection processes.
• Develops staff and fosters a quality culture within the organization.
• Communicates effectively with stakeholders to drive compliance and continuous improvement.