Senior Director, Global Distribution Quality

Position Summary:

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Ultragenyx is seeking an experiencedSenior Director Supply Chain Qualityto provideglobal quality leadership and oversightacrosspackaging labeling globallogistics distribution and external supply chain partnerssupporting bothclinical and commercial products.

This role is accountable forestablishingand maintaining arobust global Good Distribution Practice (GDP) quality framework that ensures compliant reliable and patient centricdelivery ofbiologics small molecule antisense oligonucleotide (ASO) and gene therapy products. The successful candidate will bringdeep hands-onexperience with global GDP requirements temperature controlledsupply chains and complex international distribution networks and will serve as thequality authority for supply chain operationsacross internal teams and external partners.

As a senior quality leader this rolewill shape strategy build organizational capability and drive continuous improvement across the supply chain while ensuringinspectionreadiness and regulatory compliance globally.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week or more depending on business 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 forsupply chain packaging labeling warehousing transportation and distributionactivities supporting clinical and commercial products.

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

• Serve as theQuality subject matter expertfor complex global distribution models includingcoldchain ultra-coldchain and controlled ambientlogistics.

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

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

• Ensurequality agreementsclearly define GDP responsibilities escalation pathways compliance expectations and performance metrics for all external partners.

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

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

• Serve as thequality representative for regulatory inspections and auditsrelated 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 supportdistribution network design launch readiness lifecycle management and continuous improvement while fostering a strong culture of quality and compliance.

Requirements:

• Bachelors degree inEngineering Biotechnology Pharmaceutical Sciences or a related scientific discipline; advanced degree preferred.

• 15 years of Quality Assurance experiencein the biopharmaceutical industry with substantial leadership responsibility insupply chain quality and GDP.

• Demonstratedhands-onexpertisein global GDP requirements including EU GDP U.S. distribution expectations and international regulatory standards.

• Proven experience supportingclinical and commercial distributionof temperature-sensitive products across global markets.

• Experience working withbiologics small molecules and advanced therapies(genetherapy and/or cell therapy experience strongly preferred).

• Strongtrack recordof leading and supportingregulatory inspections and audits(e.g. FDA EMA MHRA) related to supply chain and distribution.

• Deep understanding ofcGMP GDP and global regulatory expectationsacross U.S. and ex-U.S. regions.

• Demonstrated ability to effectively manage and influenceexternal partners including CMOs 3PLs andlogisticsservice providers.

• Proven senior leadership presence with the ability toinfluence without direct authorityin a matrixed fast-paced environment.
• Willingness and ability to travelapproximately 1520% including domestic and international travel asrequired.

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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