Top 4915 Regulatory compliance Jobs in Burlingame, Ca

Associate Director Clinical Quality Assurance and GxP Compliance
Ultragenyx Pharmaceutical —South San Francisco, CA
- $199,200 - $246,100 a year
- Full-time
- Hybrid work
- 7 years
- Bachelor's degree
- Children
- Gym membership
8d
FBI Special Agent: JD/Law/Legal Expertise
Federal Bureau of Investigation —San Francisco, CA
- $103,236 - $133,200 a year
- Full-time
- Master's degree
- Travel
- US work authorization
Quality and Compliance Analyst
By the Bay Health —San Mateo, CA
- $36 - $40 an hour
- Full-time
- Mid-level
- Office
- Bachelor's degree
Quick Apply
Homeless Outreach and Encampment Response Manager - Limited Term
County of San Mateo —San Mateo, CA
- $10,105.33 - $12,634.27 a month
- Online Application
- Microsoft Excel
- Public speaking
- English
- Dental insurance
- Retirement plan
Compliance Analyst
Harvey —San Francisco, CA
- $99,200 - $181,300 a year
- Full-time
- Hybrid work
- Mid-level
- Health insurance
- Dental insurance
Staff Regulatory Affairs Specialist (Remote)
Stryker —Fremont, CA
- $77,700 - $191,400 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Engineering
- Mid-level
- Health savings account
- AD&D insurance
3h
PROVIDER DISPUTE RESOLUTION SPECIALIST
NORTH EAST MEDICAL SERVICES —Burlingame, CA
- $42.79 - $48.75 an hour
- Full-time
- 5 years
- HIPAA
- Research
- Health insurance
- Dental insurance
Environmental Compliance Specialist
Hims & Hers —Menlo Park, CA
- $115,000 - $130,000 a year
- Full-time
- Remote
- 5 years
- Mid-level
- Bachelor's degree
- Employee stock purchase plan
- Health insurance
Research Compliance Analyst
University of California San Francisco —San Francisco, CA
- Full-time
- Customer service
- Computer literacy
- Bachelor's degree
Quality Assurance Specialist
AIT Worldwide Logistics, Inc. —South San Francisco, CA
- $74,840 - $105,660 a year
- Online Application
- Microsoft Word
- Customer service
- Mid-level
- Paid parental leave
- Health savings account
Compliance Coordinator
AIMS K-12 College Prep Charter District | Oakland —Oakland, CA
- $77,314.65 - $110,521.51 a year
- Full-time
- Google Workspace
- Current TB test
- Mid-level
Government Programs Compliance Specialist, Senior
Blue Shield of California —Oakland, CA
- $90,860 - $136,290 a year
- Full-time
- Hybrid work
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Work from home
Compliance and Risk Analyst
InTecAir, Inc. —Palo Alto, CA
- $120,000 - $170,000 a year
- Full-time
- Hybrid work
- Mid-level
- Office
- US work authorization
- Health insurance
- Dental insurance
Quick Apply
7d
QA Specialist II
Gilead Sciences —Foster City, CA
- $102,085 - $132,110 a year
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Health insurance
- Dental insurance
6d
COMPLIANCE & AUDIT COORDINATOR
NORTH EAST MEDICAL SERVICES —Daly City, CA
- $36.92 - $41.85 an hour
- Full-time
- Microsoft Excel
- Writing skills
- Mid-level
- Health insurance
- Dental insurance
Laboratory Coordinator
San Mateo County Community College District —San Mateo, CA
- Mid-level
- University
- Bachelor's degree
- Paid holidays
- Health insurance
6d
Human Resources Representative (2 Positions Available)
San Mateo County Community College District —San Mateo, CA
- Multiple hires
- Word processing
- Basic math
- English
- Paid holidays
- Health insurance
Regulatory Affairs Specialist II
Thermo Fisher Scientific —Fremont, CA
- $72,000 - $96,000 a year
- Full-time
- Background check
- No experience needed
- Mid-level
- Commuter assistance
- Paid parental leave
Head of Compliance
Step —San Mateo, CA
- Remote
- Bachelor's degree
- Travel
- Experience equivalent to degree accepted
- Paid parental leave
- Paid holidays
Quick Apply
9d
Compliance Assistant
Forward Logistics, Inc. —South San Francisco, CA
- $24 - $29 an hour
- Full-time
- Background check
- Writing skills
- English
- Health insurance
- Dental insurance
Quick Apply
3d

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Associate Director Clinical Quality Assurance and GxP Compliance

Ultragenyx Pharmaceutical -
South San Francisco, CA

Apply Now

Job Details

Full-time
$199,200 - $246,100 a year
8 days ago

Benefits

Gym membership

Qualifications

Regulatory inspections
Bachelor's degree

Full 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.

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

The CQA Associate Director provides strategic leadership and direction for the creation, development, and continuous evolution of quality assurance strategies, policies, programs, and initiatives. They are accountable for ensuring that organizational decisions, activities, and deliverables align with established quality standards and global health authority regulations. The Associate Director partners with senior leadership and cross-functional stakeholders to proactively evaluate and enhance quality systems, strengthen inspection readiness, and drive enterprise-wide process improvements. They champion and model a culture of compliance and quality excellence across the organization. They provide high-level oversight, guidance, and governance for the GCP Audit Program, ensuring effective planning, execution, resourcing, and risk mitigation. The Associate Director also identifies strategic opportunities to enhance operational efficiency, advance quality maturity, and support organizational growth.

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:

Serve as a senior subject matter expert (SME) on U.S. FDA, EMA, and ICH-GCP regulations, providing strategic oversight and guidance to Ultragenyx functional leaders. Direct the evaluation of non-compliances and risk areas across clinical programs and drive development of sustainable, cross-functional solutions.
Provide leadership, mentorship, and strategic direction to QA personnel, SMEs, and contract service providers in the preparation, conduct, and reporting of GCP audits. Ensure capability building that aligns with organizational needs and evolving regulatory expectations.
Oversee and govern the execution of all GCP audit types, including complex or high-risk audits (e.g., For-Cause, systemic failure evaluations). Ensure appropriate audit strategy, resourcing, and escalation pathways to support enterprise-level risk management.
Serve as the senior SME representing Clinical Quality during regulatory inspections, providing leadership on issue presentation, regulatory interactions, and cross-functional coordination. Oversee the creation, review, and approval of storyboards and inspection narratives.
Establish, direct, and oversee the enterprise Clinical Program Inspection Readiness strategy, including risk-based identification of key vendors and sites, mock inspections, war room preparation, and readiness governance. Ensure proactive alignment with Health Authority expectations.
Act as the executive CQA liaison to Records & Document Management and the Site Management Liaison (SML) team, steering continuous improvement of TMF management, clinical oversight processes, and documentation culture. Provide strategic direction to enhance regulatory compliance and operational effectiveness across teams.
Lead and prioritize Quality initiatives and department-level continuous improvement programs, ensuring alignment with organizational strategy, regulatory trends, and quality maturity objectives.

Requirements:

Bachelor's Degree is required in a scientific or related technical discipline.

At least 7+ years' experience in health-care field or setting, or in Biotech/Pharmaceutical industry with 3-6 years Quality Assurance or Compliance experience preferred.

Able to establish and execute Quality goals for a forward-looking 3-5 year period that aligns to company-wide objectives.

Broad and direct experience with leading or organizing regulatory authority inspections.

Strategic thinker, open-minded and flexible to adopting new ideas.

Excellent communications skills, both written and verbal.

Flexible in the face of shifting needs and/or priorities.

Travel: approximate 30% (if needed).
Partner & Collaborate Effectively: Listen to and value others' thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.
Support Learning & Growth: Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others.

#LI-KJ1 #LI-Hybrid

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 [email protected].

See our CCPA Employee and Applicant Privacy Notice.

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: [email protected].

Apply Now

Refine Your Search

regulatory compliance jobs in burlingame, ca

Associate Director Clinical Quality Assurance and GxP Compliance

FBI Special Agent: JD/Law/Legal Expertise

Quality and Compliance Analyst

Homeless Outreach and Encampment Response Manager - Limited Term

Compliance Analyst

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Environmental Compliance Specialist

Research Compliance Analyst

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Government Programs Compliance Specialist, Senior

Compliance and Risk Analyst

QA Specialist II

COMPLIANCE & AUDIT COORDINATOR

Laboratory Coordinator

Human Resources Representative (2 Positions Available)

Regulatory Affairs Specialist II

Head of Compliance

Compliance Assistant

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