Quality Assurance Deviation Manager

Why Join Us?   Be a hero for our rare disease patients   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.    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.   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.

Position Summary:

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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). 

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. 

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. 

Responsibilities:

1. Provide QA oversight and approval of GMP deviations generated within the QC Laboratory (including associated support groups including Lab Operations and Facilities). 
2. Guide deviation owners through investigation phases to ensure high-quality, accurate, and timely records 
3. Ensure investigations identify true root causes using established methodologies (5 Whys, Fishbone, etc.). 
4. Assess and confirm appropriate CAPAs linked to deviations, ensuring effectiveness and closure. 
5. Maintain compliance with internal procedures, regulatory expectations, and QMS requirements. 
6. Support review and approval of change controls associated with QC lab as needed. 
7. Participate in trending and data analysis activities to identify systemic issues and opportunities for improvement. 
8. Contribute to continuous improvement initiatives to enhance investigation quality and right first-time metrics. 
9. Provide QA support to other Analytical QA activities as needed. 
10. Support regulatory inspections and internal/external audits as an SME for deviations and lab investigations. 

Requirements:

1. Bachelor’s degree in a scientific discipline.  
2. Minimum 7 years of experience in GMP Quality Assurance with direct responsibility for deviations/investigations. 
3. Demonstrated proficiency in root cause analysis tools (e.g., Fishbone, 5 Whys, Ishikawa). 
4. Strong analytical and communication skills, including the ability to coach deviation owners. 
5. Experience supporting GMP QC laboratories; understanding of analytical method execution and laboratory workflows. 
6. Strong understanding of FDA, EMA, and ICH regulations applicable to biologics or gene therapy. 

Physical Demand Requirements:  

 

Lab Environment:  

• Stand for extended periods of time with periodic stooping / bending / kneeling 

• Able to lift, push, pull up to 50lbs. 

• Climb ladders and stairs of various heights. 

• 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. 

• Certain tasks may require use of a respirator; medical clearance will be required in advance. 

#LI-CS1 #LI-Onsite

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$131,800—$162,900 USD  Full Time employees across the globe enjoy a range of benefits, including, but not limited to:   ·         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 ·         Tuition 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 us at talentacquisition@ultragenyx.com.

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