Sr. Director, Global Distribution Quality
Ultragenyx, Novato, CA, United States
Position Summary
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
Stand for extended periods of time with periodic stooping / bending / kneeling
Working in temperature-controlled environments (cold rooms)
Compensation and Benefits The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range: $251,300 USD - $310,500 USD
Benefits
Generous vacation time and public holidays observed by the company
Volunteer days
Long term incentive and Employee stock purchase plans or equivalent offerings
Employee wellbeing benefits
Fitness reimbursement
Tution sponsoring
Professional development plans
Benefits vary by region and country
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing talentacquisition@ultragenyx.com.
See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Submission of unsolicited resumes prior to an agreement between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to talentacquisition@ultragenyx.com.
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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
Stand for extended periods of time with periodic stooping / bending / kneeling
Working in temperature-controlled environments (cold rooms)
Compensation and Benefits The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range: $251,300 USD - $310,500 USD
Benefits
Generous vacation time and public holidays observed by the company
Volunteer days
Long term incentive and Employee stock purchase plans or equivalent offerings
Employee wellbeing benefits
Fitness reimbursement
Tution sponsoring
Professional development plans
Benefits vary by region and country
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing talentacquisition@ultragenyx.com.
See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Submission of unsolicited resumes prior to an agreement between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to talentacquisition@ultragenyx.com.
#J-18808-Ljbffr