Sr. Director, Supply Chain QA

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Ultragenyx is seeking an experienced Senior Director, Supply Chain Quality to provide global quality leadership and oversight across packaging, labeling, global logistics, distribution, and external supply chain partners supporting both clinical and commercial products. 

This role is accountable for establishing and maintaining a robust global Good Distribution Practice (GDP) quality framework that ensures compliant, reliable, and patient centric delivery of biologics, small molecule, antisense oligonucleotide (ASO), and gene therapy products. The successful candidate will bring deep hands-on experience with global GDP requirements, temperature controlled supply chains, and complex international distribution networks, and will serve as the quality authority for supply chain operations across internal teams and external partners. 

As a senior quality leader, this role will shape strategy, build organizational capability, and drive continuous improvement across the supply chain while ensuring inspection readiness and regulatory compliance globally. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. 

Responsibilities:

• Provide global quality leadership and oversight for supply chain, packaging, labeling, warehousing, transportation, and distribution activities supporting clinical and commercial products.  

• Establish, implement, and maintain a robust global Good Distribution Practice (GDP) quality strategy, ensuring compliance with FDA, EMA, MHRA, WHO, PIC/S, and other applicable global regulations.  

• Serve as the Quality subject matter expert for complex global distribution models, including cold chain, ultra-cold chain, and controlled ambient logistics.  

• Provide QA oversight of packaging and labeling operations, including artwork approval, labeling controls, serialization/traceability, tamper-evident systems, and country-specific labeling requirements.  

• Lead qualification, oversight, and performance monitoring of external supply chain partners, including CMOs, 3PLs, freight forwarders, depots, and packaging vendors.  

• Ensure quality agreements clearly define GDP responsibilities, escalation pathways, compliance expectations, and performance metrics for all external partners.  

• Integrate GDP processes into the Quality Management System (QMS), including deviations, CAPAs, change control, complaints, risk management, and management review.  

• Lead and oversee investigations related to temperature excursions, shipment deviations, labeling errors, and distribution complaints, ensuring effective root cause analysis and sustainable corrective and preventive actions.  

• Serve as the quality representative for regulatory inspections and audits related to supply chain, distribution, packaging, and labeling, and support Health Authority and Qualified Person (QP) interactions.  

• Partner cross-functionally with Supply Chain, Technical Operations, Regulatory Affairs, Clinical Operations, and Commercial teams to support distribution network design, launch readiness, lifecycle management, and continuous improvement, while fostering a strong culture of quality and compliance. 

Requirements:

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.  

• 15+ years of Quality Assurance experience in the biopharmaceutical industry, with substantial leadership responsibility in supply chain quality and GDP.  

• Demonstrated hands-on expertise in global GDP requirements, including EU GDP, U.S. distribution expectations, and international regulatory standards.  

• Proven experience supporting clinical and commercial distribution of temperature-sensitive products across global markets.  

• Experience working with biologics, small molecules, and advanced therapies (gene therapy and/or cell therapy experience strongly preferred).  

• Strong track record of leading and supporting regulatory inspections and audits (e.g., FDA, EMA, MHRA) related to supply chain and distribution.  

• Deep understanding of cGMP, GDP, and global regulatory expectations across U.S. and ex-U.S. regions.  

• Demonstrated ability to effectively manage and influence external partners, including CMOs, 3PLs, and logistics service providers.  

• Proven senior leadership presence with the ability to influence without direct authority in a matrixed, fast-paced environment.  

• Willingness and ability to travel approximately 15–20%, including domestic and international travel, as required. 

Physical Demand Requirements: 

• Stand for extended periods of time with periodic stooping / bending / kneeling 

• Working in temperature-controlled environments (cold rooms)  

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