Back to jobs
New

Senior Manager, Clinical QA & GxP Compliance

Brisbane, CA
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:

The primary responsibility of this role is to provide oversight of GCP activities which include, but are not limited to: ensuring patient safety, data integrity and compliance with SOPs, GCP and applicable regulations. Additional responsibilities include execution of the GCP Audit Plan as well as support of Inspection Management goals and objectives.  

ultrainnovative – Tackle rare and dynamic challenges

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:

  • Plan, conduct or manage, and report results for GxP audits which includes but is not limited to internal processes, clinical investigational sites, clinical vendors, CSRs and TMFs
  • Train, coach and oversee Clinical QA personnel, subject matter experts (SMEs) and/or other contract service provider(s) in preparing, conducting, and reporting of GxP audits, as assigned 
  • Actively support inspection readiness activities, associated Health Authority Inspections and perform assigned War Room leadership role through the following: 
    • Participate in cross functional teams to identify GxP inspection risks and lead activities to mitigate and defend business processes, for example through storyboard process 
    • Identify and communicate potential risks 
    • Develop and deliver inspection training for SMEs and War Room support team members 
    • Lead partnerships with key stakeholders to deliver forward-thinking programs and training facilitating a state of inspection readiness 
  • Review GCP-associated controlled documents which may include standard operation procedures (SOPs), protocols/amendments, study-specific documents such as study or data management plans, etc., in accordance with applicable regulatory requirements (e.g., ICH E6, U.S. FDA, EMA, and local regulations) 
  • Provide guidance and support to internal departments and Clinical Study teams (during all phases of clinical development) in the identification and investigation of potential GCP and compliance issues, including those at clinical investigator sites, with internal Ultragenyx processes, and with vendors conducting GCP activities
  • Ensure appropriate and timely solutions for corrective and preventive actions are implemented at sites or vendors, when needed to secure compliance and maintain a state of inspection readiness
  • Ensure proper evaluation and completeness of deviation/CAPA entries; project manage process to ensure timely completion and closure of deviations/CAPAs, to ensure triage and report metrics and trends to management
  • Perform any other tasks as requested by Clinical QA and/or Executive Management to support Quality oversight activities 

Requirements:

  • Bachelor's Degree is required in a scientific or related technical discipline 
  • At least 7+ years’ experience in Biotech/Pharmaceutical industry, Quality Assurance experience preferred 
  • Strong working knowledge and interpretation of global GCPs, particularly U.S. FDA / EU and ICH regulations and guidelines 
  • Able to execute quality goals over a 1-2 year period that aligns to company-wide objectives 
  • Excellent communications skills, both written and verbal 
  • Flexible in the face of shifting needs and/or priorities 
  • Motivated, committed and self-managed 
  • Travel up to 30% of the time 

#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.

Pay Range

$171,200 - $211,500 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.

See our Privacy Policy.

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.

Create a Job Alert

Interested in building your career at Ultragenyx Pharmaceutical? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification Survey

We are dedicated to fostering an inclusive workplace environment that keeps our teams inspired, empowered, and free to share new ideas—and to better finding solutions that advance the treatment of those living with rare diseases.  We invite you to voluntarily provide demographic information in a confidential survey at the end of this application to assist us in complying with legal requirements and managing our organization. Providing this information is completely optional and it will not be accessible or used by those involved in your hiring or decision-making process. Your response – or decision not to respond, has no impact on your opportunity for employment. Responses to the voluntary self-identification requests will be confidential and securely maintained and only reported in the aggregate in support of the efforts outlined above.

Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Ultragenyx Pharmaceutical’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.