Ultragenyx

Associate Director, Global Inspection Management

Ultragenyx  •  $180k - $222k/yr  •  Hybrid  •  18 days ago
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Job Description

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

ultracurious – Apply your biggest ideas in courageous ways

We are seeking a dynamic and experienced Associate Director of GMP Inspection Management to execute a global inspection readiness and management program. The role is accountable for the successful execution of all inspection management and readiness activities across the Ultragenyx network. This role will be responsible for ensuring consistent, proactive, and risk-based inspection readiness across internal manufacturing and testing operations, as well as external Contract Manufacturing Organizations (CMOs). The ideal candidate will bring strongexpertise in GMP compliance, regulatory inspections, and cross-functional collaboration to drive a culture of continuous improvement and inspection excellence.

Work Model:

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.

Responsibilities:

Global Inspection Strategy & Readiness

  1. Support the implementation of a comprehensive global GMP inspection management framework and governance
  2. Support inspection readiness initiatives across internal and external manufacturing and testing sites
  3. Develop and maintain inspection storyboards/playbooks, mock inspection protocols, and response templates
  4. Monitor and report inspection management and readiness performance metrics

Inspection Execution & Management

  1. Support regulatory GMP inspections (FDA, EMA, PMDA, etc.), including coordination, and response management as needed
  2. Oversee inspection logistics, real-time support, and post-inspection follow-up activities

External Manufacturing Oversight

  1. Partner with Quality, Manufacturing, and Supply Chain teams to ensure CMO sites are inspection ready
  2. Participate in inspection readiness assessments and support CMOs during regulatory inspections

Training & Continuous Improvement

  1. Deliver inspection training programs for SMEs and inspection teams
  2. Analyze inspection trends and regulatory intelligence to inform risk mitigation strategies
  3. Drive continuous improvement in inspection readiness processes and tools.

Leadership & Collaboration

  1. Participate in cross-functional inspection readiness teams and governance forums.
  2. Collaborate with Global Quality, Regulatory Affairs, and Compliance teams to align on inspection strategy.

Requirements:

  1. Bachelor’s degree in Life Sciences or related field
  2. 12+ years of experience in GMP compliance, quality assurance, or regulatory affairs within the biopharmaceutical industry
  3. Proven track record of leading global regulatory inspections and readiness programs
  4. Strong knowledge of global GMP regulations and inspection practices
  5. Experience with both internal operations and external manufacturing oversight
  6. Excellent communication and project management skills
  7. Ability to influence across levels and functions in a matrixed organization
  8. Experience with biologics or gene therapy manufacturing
  9. Prior experience working with global CMOs and managing complex supply chains
  10. Familiarity with digital tools for inspection management and quality systems
  11. Up to 25% travel may be required (Domestic and International)

#LI-KJ1 #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.

Pay Range
$179,600$221,900 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

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.

Note to External Recruiters 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 talentacquisition@ultragenyx.com
Ultragenyx

About Ultragenyx

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

Industry
Biotech & Life Sciences
Company Size
1,001-5,000 employees
Headquarters
Novato, California
Year Founded
2010
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