Director External Quality Assurance

About the role

Ultragenyx is seeking a Director of External Quality Assurance to lead CMC QA activities across manufacturing operations. The role reports to the Senior Director of CMC QA and is responsible for shaping the quality strategy for assigned programs while managing external partnerships.

Key responsibilities

• Develop and implement Ultragenyx’s CMC quality approach for assigned drug substance and product programs.
• Provide quality oversight from clinical through commercial development, ensuring compliance with cGMP regulations.
• Review and approve investigations, root‑cause analyses, and corrective actions for manufacturing and laboratory operations.
• Oversee resolution of quality events, monitor escalations, and ensure proper disposition of impacted product.
• Approve changes to facilities, computerized systems, laboratories, and products.
• Perform final review of test data and reports to confirm conformance with specifications and SOPs.
• Independently manage external quality partnerships and collaborate with Technical Operations.

Required profile

• Extensive experience in CMC quality assurance within the biopharma industry.
• Strong leadership and management skills, with the ability to drive cross‑functional initiatives.
• Deep knowledge of cGMP regulatory requirements and quality systems.
• Proven ability to manage external vendors and partnerships.

Required skills

• cGMP compliance
• Quality Management Systems (QMS)
• Investigation and root‑cause analysis
• Change control processes
• Manufacturing operations oversight

What we offer

• Hybrid work model with 2‑3 days onsite per week.
• Opportunity to impact rare‑disease patients through innovative therapies.
• Supportive, inclusive culture focused on professional growth.