Director of Quality Assurance

Position: Director of Quality Assurance, Ultragenyx
Join Ultragenyx as the Director of Quality Assurance for CMC, guiding QA efforts for innovative therapies. This role emphasizes strategic quality management across multiple drug modalities.

In the capacity of Director, CMC QA, you will provide strategic direction for quality oversight across a range of biopharmaceutical products. Your leadership will span a team of 8 to 12 quality professionals, focusing on compliance with industry regulations and Ultragenyx's high standards. Close collaboration with cross-functional teams is key to ensuring rigorous QA throughout the product lifecycle.

Key Responsibilities:

• Establish CMC QA goals and operational strategies

• Coach and develop QA team for optimal performance

• Guarantee compliance with international regulatory standards

• Supervise quality risk management processes

• Facilitate regulatory submission leadership and governance

Requirements:

• Bachelor’s or advanced degree in a relevant discipline

• 15+ years of experience in regulated industries

• 10+ years of leadership in quality management

• Proficiency in GMP and quality oversight

• Strong collaboration and communication skills

Drive excellence in CMC quality assurance while supporting life-changing therapies at Ultragenyx.
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