Novato, California, United States · Hybrid
$216k–$266k/yr
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 …
Skills: CMC Quality Assurance, GMP Manufacturing, Regulatory Compliance, Risk Management, External Partnership Management
United States · Remote OK
$187k–$231k/yr
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 …
Skills: Strategic Planning, Clinical Research, Drug Development, GCP Guidelines, Real World Evidence
United States · Remote OK
$207k–$255k/yr
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 …
Skills: Clinical Vendor Management, Strategic Sourcing, Contracting Alignment, Vendor Governance, RFI/RFP Leadership
United States · Remote OK
$209k–$258k/yr
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 …
Skills: Patient Access, Reimbursement Management, People Management, Conflict Resolution, Cross-functional Collaboration
United States · Remote OK
$191k–$236k/yr
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 …
Skills: Scientific Communications, Publication Planning, Strategic Narrative Development, Clinical Data Interpretation, Medical Affairs Strategy
Tokyo, Japan · Remote OK
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 …
Skills: Pharmaceutical Marketing, Rare Disease Strategy, Budget Management, Market Modelling, Forecasting
Tokyo, Japan · Remote OK
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 …
Skills: Pharmaceutical Marketing, Rare Disease Strategy, Gene Therapy, Market Access, HCP Engagement
Bedford, England, United Kingdom · On-site
$23/hr–$30/hr
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 …
Skills: General Filtration, Tangential Flow Filtration, Column Chromatography, Aseptic Technique, SOP Writing
Bedford, England, United Kingdom · On-site
$78k–$97k/yr
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 …
Skills: Cell Thaw, Cell Culture, Bioreactor Operation, Harvest Operations, cGMP
Bedford, England, United Kingdom · On-site
$78k–$97k/yr
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 …
Skills: Upstream Manufacturing, Cell Thaw, Cell Culture, Bioreactor Operation, Harvest Operations
Buenos Aires, Argentina · Remote OK
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 …
Skills: KOL Relationship Management, Clinical Data Interpretation, Scientific Communication, Clinical Research Support, Market Insight Gathering
Bedford, England, United Kingdom · On-site
$107k–$133k/yr
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 …
Skills: GMP Compliance, Facilities Management, Maintenance Planning, CMMS Proficiency, Root Cause Analysis
Bedford, England, United Kingdom · On-site
$91k–$112k/yr
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 …
Skills: HVAC System Design, Utility System Design, Commissioning, Troubleshooting, P&ID Reading
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The Director of CMC QA provides quality oversight for drug substance and product development to ensure compliance with cGMP regulatory requirements. This includes managing external partnerships, overseeing quality event resolutions, and approving manufacturing investigations and changes.
Requires a Bachelor's degree in Engineering, Biotechnology, or Biological/Physical sciences with over 10 years of experience in GMP biopharmaceutical manufacturing. Candidates must have strong knowledge of FDA/EMA regulations and experience with risk management tools and regulatory inspections.
ultrafocused – Work together to fearlessly uncover new possibilities
The Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations, developing and implementing Ultragenyx CMC Quality approach for assigned programs, and working with colleagues to improve processes utilized to ensure product quality. In addition, this position will use strong management skills to independently manage external partnerships.
In this role, in collaboration with key stakeholders in Technical Operations, DIR CMC QA provides quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.
Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.
#LI-CS1 #LI-Hybrid
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.
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 [email protected].
Going Beyond Every Day
Leading with purpose. Every day. “Ultragenyx was founded to advance innovative medicines for rare and ultrarare diseases that have never been treated before. We are delivering transformative therapies across multiple indications, and we have one of the most robust and diverse clinical pipelines in rare disease. Our focus is on doing the right things for patients both during development and commercialization to deliver on the promise of these therapies in a way that's meaningful for rare disease communities.” Emil D. Kakkis, M.D., Ph.D. Chief Executive Officer and President We have an inclusive culture of value and respect. 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! Visit our community guidelines at: https://ultragenyx.co/community
Offices: 60 Leveroni Ct, Novato, California 94949, US · 5000 Marina Blvd, Brisbane, California 94005, US · 8001 Redwood Blvd, Novato, California 94945, US · Avenida Santa Fe 94, Santa Fe, Zedec Sta Fe, Mexico City, 01219, MX · Calle 90 #11-13, Ofc. 417, Bogota, CO
Going Beyond Every Day
Leading with purpose. Every day. “Ultragenyx was founded to advance innovative medicines for rare and ultrarare diseases that have never been treated before. We are delivering transformative therapies across multiple indications, and we have one of the most robust and diverse clinical pipelines in rare disease. Our focus is on doing the right things for patients both during development and commercialization to deliver on the promise of these therapies in a way that's meaningful for rare disease communities.” Emil D. Kakkis, M.D., Ph.D. Chief Executive Officer and President We have an inclusive culture of value and respect. 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! Visit our community guidelines at: https://ultragenyx.co/community
Offices: 60 Leveroni Ct, Novato, California 94949, US · 5000 Marina Blvd, Brisbane, California 94005, US · 8001 Redwood Blvd, Novato, California 94945, US · Avenida Santa Fe 94, Santa Fe, Zedec Sta Fe, Mexico City, 01219, MX · Calle 90 #11-13, Ofc. 417, Bogota, CO
