Quality Assurance Deviation Manager

<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">The QA Deviation Manager is responsible for providing quality oversight of GMP deviations within a QC Laboratory supporting gene therapy programs. This role partners closely with deviation owners to ensure timely, compliant, and thorough completion of investigations and associated quality records. The position also supports change controls, CAPAs, and regulatory inspections as part of the site Quality Management System (QMS).</span><span data-ccp-props="{"201341983":0,"335559740":256}"> </span></p> <p><span data-contrast="auto">This is an onsite, hands-on QA role requiring strong GMP knowledge, investigative expertise, and the ability to influence in a fast paced, highly regulated environment.</span><span data-ccp-props="{"201341983":0,"335559740":256}"> </span></p> <h3 style="text-align: left;"><strong>Work Model: </strong></h3> <p style="text-align: left;">Core Lab Ops: This role typically requires that the majority of the work be conducted on-site.<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> <ol> <li style="line-height: 2;"><span data-contrast="auto">Provide QA oversight and approval of GMP deviations generated within the QC Laboratory (including associated support groups including Lab Operations and Facilities).</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Guide deviation owners through investigation phases to ensure high-quality, accurate, and timely records</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Ensure investigations identify true root causes using established methodologies (5 Whys, Fishbone, etc.).</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Assess and confirm appropriate CAPAs linked to deviations, ensuring effectiveness and closure.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Main ... (truncated, view full listing at source)