Senior Manager QA Operations Drug Substance (M-F, 2:30 pm - 10:00 pm)

<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 style="text-align: left;"><span class="TextRun SCXW14376707 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW14376707 BCX8">The Senior Manager of Quality Assurance Operations Drug Substance will </span><span class="NormalTextRun SCXW14376707 BCX8">be responsible for</span><span class="NormalTextRun SCXW14376707 BCX8"> Quality oversite of the Gene Therapy Manufacturing Facility (GTMF) Drug Substance manufacturing area</span><span class="NormalTextRun SCXW14376707 BCX8">. </span><span class="NormalTextRun SCXW14376707 BCX8">This individual will </span><span class="NormalTextRun SCXW14376707 BCX8">operate</span><span class="NormalTextRun SCXW14376707 BCX8"> with a quality mindset and provide "on the floor" oversite of manufacturing activities which includes but is not limited to "on the floor" guidance during unexpected events, batch record review, line clearance, and deviation and change control management</span><span class="NormalTextRun SCXW14376707 BCX8">. </span><span class="NormalTextRun SCXW14376707 BCX8">You will partner with Manufacturing, Engineering, Facilities, MSAT, Validation, and Quality Control teams to support manufacturing and product release activities as well as ongoing projects, </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW14376707 BCX8">initiatives</span><span class="NormalTextRun SCXW14376707 BCX8"> and reports</span><span class="NormalTextRun SCXW14376707 BCX8">. </span><span class="NormalTextRun SCXW14376707 BCX8">You will provide quality </span><span class="NormalTextRun SCXW14376707 BCX8">expertise</span><span class="NormalTextRun SCXW14376707 BCX8"> to ensure compliant manufacture of GMP material (clinical or commercial)</span><span class="NormalTextRun SCXW14376707 BCX8">. </span><span class="NormalTextRun SCXW14376707 BCX8">In this role, operational excellence initiatives must be supported and driven. Supervision and mentoring of junior level team members to clarify goals and priorities may be </span><span class="NormalTextRun SCXW14376707 BCX8">required</span><span class="NormalTextRun SCXW14376707 BCX8">. You will </span><span class="NormalTextRun SCXW14376707 BCX8">be required</span><span class="NormalTextRun SCXW14376707 BCX8"> to set goals for your team and ensu ... (truncated, view full listing at source)