Job Description
Position Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
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:
- Provide QA oversight and approval of GMP deviations generated within the QC Laboratory (including associated support groups including Lab Operations and Facilities).
- Guide deviation owners through investigation phases to ensure high-quality, accurate, and timely records
- Ensure investigations identify true root causes using established methodologies (5 Whys, Fishbone, etc.).
- Assess and confirm appropriate CAPAs linked to deviations, ensuring effectiveness and closure.
- Maintain compliance with internal procedures, regulatory expectations, and QMS requirements.
- Support review and approval of change controls associated with QC lab as needed.
- Participate in trending and data analysis activities to identify systemic issues and opportunities for improvement.
- Contribute to continuous improvement initiatives to enhance investigation quality and right first-time metrics.
- Provide QA support to other Analytical QA activities as needed.
- Support regulatory inspections and internal/external audits as an SME for deviations and lab investigations.
Requirements:
- Bachelor’s degree in a scientific discipline.
- Minimum 7 years of experience in GMP Quality Assurance with direct responsibility for deviations/investigations.
- Demonstrated proficiency in root cause analysis tools (e.g., Fishbone, 5 Whys, Ishikawa).
- Strong analytical and communication skills, including the ability to coach deviation owners.
- Experience supporting GMP QC laboratories; understanding of analytical method execution and laboratory workflows.
- Strong understanding of FDA, EMA, and ICH regulations applicable to biologics or gene therapy.
Physical Demand Requirements:
Lab Environment: #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. 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. 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.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Position Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
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:
- Provide QA oversight and approval of GMP deviations generated within the QC Laboratory (including associated support groups including Lab Operations and Facilities).
- Guide deviation owners through investigation phases to ensure high-quality, accurate, and timely records
- Ensure investigations identify true root causes using established methodologies (5 Whys, Fishbone, etc.).
- Assess and confirm appropriate CAPAs linked to deviations, ensuring effectiveness and closure.
- Maintain compliance with internal procedures, regulatory expectations, and QMS requirements.
- Support review and approval of change controls associated with QC lab as needed.
- Participate in trending and data analysis activities to identify systemic issues and opportunities for improvement.
- Contribute to continuous improvement initiatives to enhance investigation quality and right first-time metrics.
- Provide QA support to other Analytical QA activities as needed.
- Support regulatory inspections and internal/external audits as an SME for deviations and lab investigations.
Requirements:
- Bachelor’s degree in a scientific discipline.
- Minimum 7 years of experience in GMP Quality Assurance with direct responsibility for deviations/investigations.
- Demonstrated proficiency in root cause analysis tools (e.g., Fishbone, 5 Whys, Ishikawa).
- Strong analytical and communication skills, including the ability to coach deviation owners.
- Experience supporting GMP QC laboratories; understanding of analytical method execution and laboratory workflows.
- Strong understanding of FDA, EMA, and ICH regulations applicable to biologics or gene therapy.
Physical Demand Requirements:
Lab Environment: #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. 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. 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.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
About Ultragenyx
Ultragenyx brings novel products to those living with rare and ultrarare diseases with a focus on debilitating genetic diseases. Founded in 2010, we have rapidly built a diverse portfolio of approved therapies and products aimed at diseases with a high unmet medical need for which many have no approved therapies. It takes courage, care, talent, and dedication to make a meaningful impact for those living with rare diseases, their families and the rare disease community.
We put our people first, so they can take care of the rare disease community.
We purposefully cultivate and nurture a dynamic, supportive work environment where we encourage every team member to share their new ideas and help us unlock more possibilities. Our team is made up of exceptional and diverse people with a strong passion and commitment to helping those living with rare diseases. By embracing generosity, curiosity, inclusion, and humility we are constantly learning together—fostering an environment that supports profound growth and fulfillment.
If you want to have a meaningful impact, do the best work of your career while having fun and growing professionally and personally, come join our team!
