Executive Director, CMC QA

Position: Ultragenyx Executive Director, CMC QA
Lead quality assurance initiatives at Ultragenyx as the Executive Director for CMC QA. This strategic role focuses on enhancing biopharmaceutical quality across diverse programs and modalities.

As the Executive Director, CMC QA, you'll provide crucial leadership over quality assurance for biologics, small molecules, and gene therapies.

Your role involves overseeing CMC QA responsibilities for starting materials and drug products while managing a dedicated team of 8-12 professionals. You'll also collaborate closely with Technical Operations, Product Development, and Regulatory Affairs, ensuring compliance with global standards.

Key Responsibilities:

• Set CMC QA vision and strategy for Ultragenyx

• Lead a high-performing team in program and CMO QA

• Ensure compliance with global regulatory requirements

• Drive risk-based oversight of external manufacturing

• Oversee quality risk management strategies and metrics

Requirements:

• Bachelor’s or advanced degree in a related field

• 15+ years in biotech or pharmaceutical industries

• 10+ years of leadership in FDA/EMA environments

• Expertise in global GMP requirements

• Strong CMC strategy for rare disease product development

Elevate CMC quality standards and make a tangible impact on patient care at Ultragenyx.
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