Sr. Director, Supply Chain QA

<div class="content-intro"><div><strong>Why Join Us?</strong></div> <div> </div> <div><em>Be a hero for our rare disease patients</em></div> <div><em> </em></div> <div>At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. </div> <div> </div> <div>Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.</div> <div> </div> <div>If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team<em>. </em></div></div><h3 style="text-align: left;"><strong>Position Summary:</strong></h3> <p style="text-align: left;"><strong><em>ultra</em></strong><em>focused – Work together to fearlessly uncover new possibilities</em></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Ultragenyx is seeking an experienced </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">Senior Director, Supply Chain Quality</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)"> to provide </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">global quality leadership and oversight</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)"> across </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">packaging, labeling, global </span><span data-ccp-charstyle="Strong">logistics</span><span data-ccp-charstyle="Strong">, distribution, and external supply chain partners</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)"> supporting both </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">clinical and commercial products</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":2,"335559740":300}"> </span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">This role is accountable for </span><span data-ccp-parastyle="Normal (Web)">establishing</span><span data-ccp-parastyle="Normal (Web)"> and maintaining a </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">robust global Good Distribution Practice (GDP) quality framework</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)"> that ensures compliant, reliable, and patient centric</span><span data-ccp-parastyle="Normal (Web)"> delivery of </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">biologics, small molecule, antisense oligonucleotide (ASO), and gene therapy products</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">. The successful candidate will bring </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">deep hands-on</span><span data-ccp-charstyle="Strong"> experience with global GDP requirements</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">, temperature controlled</span><span data-ccp-parastyle="Normal (Web)"> supply chains, and complex international distribution networks, and will serve as the </span></span><strong><span data-contrast="auto"><span data-ccp-charstyle="Strong">quality authority for supply chain operations</span></span></strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)"> across internal teams and external partners.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":2,"335559740":300}"> </span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">As a senior quality leader, this role</span><span data-ccp-parastyle="Normal (Web)"> will shape strategy, build organizational capability, and drive continuous improvement across the supply chain while ensuring </span><span data-ccp-parastyle="Normal (Web)">inspection</span><span data-ccp-parastyle="Normal (Web)"> readiness and regulatory compliance globally.</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":2,"335559740":300}"> </span></p> <h3 style="text-align: left;"><strong>Work Model: </strong></h3> <p style="text-align: left;">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.<span class="EOP SCXW179329379 BCX0" data-ccp-props="{"201341983":0,"335559739":120,"335559740":240}"> </span></p> <h3 style="text-align: left;"><strong>Responsibilities:</strong></h3> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1"><span data-contrast="auto">Provide global quality leadership and oversight for </span><strong><span data-contrast="auto">supply chain, packaging, labeling, warehousing, transportation, and distribution</span></strong><span data-contrast="auto"> activities supporting clinical and commercial products. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Establish, implement, and maintain a </span><strong><span data-contrast="auto">robust global Good Distribution Practice (GDP) quality strategy</span></strong><span data-contrast="auto">, ensuring compliance with FDA, EMA, MHRA, WHO, PIC/S, and other applicable global regulations. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Serve as the </span><strong><span data-contrast="auto">Quality subject matter expert</span></strong><span data-contrast="auto"> for complex global distribution models, including </span><strong><span data-contrast="auto">cold chain, ultra-cold chain, and controlled ambient logistics</span></strong><span data-contrast="auto">. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Provide QA oversight of </span><strong><span data-contrast="auto">packaging and labeling operations</span></strong><span data-contrast="auto">, including artwork approval, labeling controls, serialization/traceability, tamper-evident systems, and country-specific labeling requirements. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Lead qualification, oversight, and performance monitoring of </span><strong><span data-contrast="auto">external supply chain partners</span></strong><span data-contrast="auto">, including CMOs, 3PLs, freight forwarders, depots, and packaging vendors. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Ensure </span><strong><span data-contrast="auto">quality agreements</span></strong><span data-contrast="auto"> clearly define GDP responsibilities, escalation pathways, compliance expectations, and performance metrics for all external partners. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Integrate GDP processes into the </span><strong><span data-contrast="auto">Quality Management System (QMS)</span></strong><span data-contrast="auto">, including deviations, CAPAs, change control, complaints, risk management, and management review. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Lead and oversee investigations related to </span><strong><span data-contrast="auto">temperature excursions, shipment deviations, labeling errors, and distribution complaints</span></strong><span data-contrast="auto">, ensuring effective root cause analysis and sustainable corrective and preventive actions. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Serve as the </span><strong><span data-contrast="auto">quality representative for regulatory inspections and audits</span></strong><span data-contrast="auto"> related to supply chain, distribution, packaging, and labeling, and support Health Authority and Qualified Person (QP) interactions. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Partner cross-functionally with Supply Chain, Technical Operations, Regulatory Affairs, Clinical Operations, and Commercial teams to support </span><strong><span data-contrast="auto">distribution network design, launch readiness, lifecycle management, and continuous improvement</span></strong><span data-contrast="auto">, while fostering a strong culture of quality and compliance.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <h3 style="text-align: left;"><strong>Requirements:</strong></h3> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Bachelor’s degree in </span><strong><span data-contrast="auto">Engineering, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline</span></strong><span data-contrast="auto">; advanced degree preferred. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><strong><span data-contrast="auto">15+ years of Quality Assurance experience</span></strong><span data-contrast="auto"> in the biopharmaceutical industry, with substantial leadership responsibility in </span><strong><span data-contrast="auto">supply chain quality and GDP</span></strong><span data-contrast="auto">. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">Demonstrated </span><strong><span data-contrast="auto">hands-on expertise in global GDP requirements</span></strong><span data-contrast="auto">, including EU GDP, U.S. distribution expectations, and international regulatory standards. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="auto">Proven experience supporting </span><strong><span data-contrast="auto">clinical and commercial distribution</span></strong><span data-contrast="auto"> of temperature-sensitive products across global markets. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="auto">Experience working with </span><strong><span data-contrast="auto">biologics, small molecules, and advanced therapies</span></strong><span data-contrast="auto"> (gene therapy and/or cell therapy experience strongly preferred). </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="15" data-aria-level="1"><span data-contrast="auto">Strong track record of leading and supporting </span><strong><span data-contrast="auto">regulatory inspections and audits</span></strong><span data-contrast="auto"> (e.g., FDA, EMA, MHRA) related to supply chain and distribution. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="16" data-aria-level="1"><span data-contrast="auto">Deep understanding of </span><strong><span data-contrast="auto">cGMP, GDP, and global regulatory expectations</span></strong><span data-contrast="auto"> across U.S. and ex-U.S. regions. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="17" data-aria-level="1"><span data-contrast="auto">Demonstrated ability to effectively manage and influence </span><strong><span data-contrast="auto">external partners</span></strong><span data-contrast="auto">, including CMOs, 3PLs, and logistics service providers. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="18" data-aria-level="1"><span data-contrast="auto">Proven senior leadership presence with the ability to </span><strong><span data-contrast="auto">influence without direct authority</span></strong><span data-contrast="auto"> in a matrixed, fast-paced environment. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1"><span data-contrast="auto">Willingness and ability to travel </span><strong><span data-contrast="auto">approximately 15–20%</span></strong><span data-contrast="auto">, including domestic and international travel, as required.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559738":240,"335559740":256}"> </span></p> <p><strong><span data-contrast="auto">Physical Demand Requirements</span></strong><strong><span data-contrast="auto">:</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":256}"> </span></p> <p><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":256}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Stand for extended periods of time with periodic stooping / bending / kneeling</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="35" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Working in temperature-controlled environments (cold rooms)</span><strong><span data-contrast="auto"> </span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p> </p> <p><span style="color: rgb(255, 255, 255);"><strong>#LI-CS1 <span class="ui-provider dir dis c d e f g h i j k l m n o p q r s t dit diu w x y z ab ac ae af ag ah ai aj ak">#LI-Hybrid</span></strong></span></p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p><em>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.</em></p> <p><em><br>This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.</em></p></div><div class="title">Pay Range</div><div class="pay-range"><span>$251,300</span><span class="divider">—</span><span>$310,500 USD</span></div></div></div><div class="content-conclusion"><div> </div> <div><strong><em>Full Time employees across the globe enjoy a range of benefits, including, but not limited to:</em></strong></div> <div> </div> <div><strong><em>·         Generous vacation time and public holidays observed by the company</em></strong></div> <div><strong><em>·         Volunteer days</em></strong></div> <div><strong><em>·         Long term incentive and Employee stock purchase plans or equivalent offerings</em></strong></div> <div><strong><em>·         Employee wellbeing benefits</em></strong></div> <div><strong><em>·         Fitness reimbursement</em></strong></div> <div><strong><em>·         Tuition sponsoring</em></strong></div> <div><strong><em>·         Professional development plans</em></strong></div> <div> </div> <div><em>* Benefits vary by region and country</em></div> <div> <p><strong>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 us at </strong><a href="mailto:talentacquisition@ultragenyx.com"><strong>talentacquisition@ultragenyx.com</strong></a><strong>.</strong></p> </div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/CCPA-Notice/"><em>CCPA Employee and Applicant Privacy Notice</em></a><em>.</em></div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/privacy-policy/">Privacy Policy</a><em>.</em></div> <div> <p><strong>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.</strong></p> </div> <div><strong>Note to External Recruiters</strong>: 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. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place 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<em>: </em><a class="postings-link" href="http://mailto:talentacquisition@ultragenyx.com/">talentacquisition@ultragenyx.com</a><em>.</em></div></div>