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">Maintain compliance with internal procedures, regulatory expectations, and QMS requirements.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Support review and approval of change controls associated with QC lab as needed.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Participate in trending and data analysis activities to identify systemic issues and opportunities for improvement.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Contribute to continuous improvement initiatives to enhance investigation quality and right first-time metrics.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Provide QA support to other Analytical QA activities as needed.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Support regulatory inspections and internal/external audits as an SME for deviations and lab investigations.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ol> <h3 style="text-align: left;"><strong>Requirements:</strong></h3> <ol> <li style="line-height: 2;"><span data-contrast="auto">Bachelor’s degree in a scientific discipline. </span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Minimum 7 years of experience in GMP Quality Assurance with direct responsibility for deviations/investigations.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Demonstrated proficiency in root cause analysis tools (e.g., Fishbone, 5 Whys, Ishikawa).</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Strong analytical and communication skills, including the ability to coach deviation owners.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Experience supporting GMP QC laboratories; understanding of analytical method execution and laboratory workflows.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Strong understanding of FDA, EMA, and ICH regulations applicable to biologics or gene therapy.</span><span data-ccp-props="{"201341983":2,"335559739":0,"335559740":300}"> </span></li> </ol> <p><strong><span data-contrast="auto">Physical Demand Requirements: </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> <p><strong><span data-contrast="auto">Lab Environment</span></strong><span data-contrast="auto">: </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":256}"> </span></p> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="25" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"multilevel"}" 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":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="25" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Able to lift, push, pull up to 50lbs.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="25" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Climb ladders and stairs of various heights.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="25" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="25" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Certain tasks may require use of a respirator; medical clearance will be required in advance.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <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-Onsite</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>$131,800</span><span class="divider">—</span><span>$162,900 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>