Notifications

Ultragenyx
3.4
Executive Director, CMC QA
Novato, CA
$294K - $363K (Employer provided)
Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.…
17d
Ultragenyx
3.4
Executive Director, CMC QA
South San Francisco, CA
$294K - $363K (Employer provided)
Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.…
17d
Ultragenyx
3.4
Manager, QA Product Disposition
Bedford, MA
$132K - $163K (Employer provided)
Lead and support disposition-related quality activities across internal and external manufacturing sites, ensuring continuity through effective backup coverage,……
10d
CorVel
2.8
Security Analyst I
United States
$70K - $117K (Employer provided)
Easy Apply
1 to 3 years of experience in information security, IT, or related field. This entry‑level role contributes to protecting company data, supporting audit……
25d
information security analyst jobs in United States CorVel jobs in United States
CorVel salaries information security analyst salaries in United States
Employee reviews at CorVel CorVel interview experience Working at CorVel
Amberwell Health
3.3
Director of Emergency Care
Hiawatha, KS
$57K - $97K (Glassdoor est.)
Ensures compliance with certification and accreditation standards in accordance with Amberwell policies and procedures. Attends other meetings as necessary.…
30d+
USC Perinatal Group
Specialized Imaging Technologist - Perinatology / High-Risk Pregnancy
Los Angeles, CA
$47.00 - $49.00 Per Hour (Employer provided)
Easy Apply
As an employee of USC, you will be a part of a world-class research university and a member of the “Trojan Family," which is comprised of the faculty, students……
30d+
Wallace Electric
4.5
Commercial and Industrial Electrical Project Executive
Atlanta, GA
$150K - $175K (Employer provided)
Easy Apply
*Master Electrician License* or equivalent state electrical license. *DBIA Design-Build Professional™* certification (preferred for design-build project……
5d
Capstone Rural Health
4.2
Licensed Practical Nurse
Jasper, AL
$57K - $72K (Glassdoor est.)
Easy Apply
Current and unrestricted Licensed Practical Nurse (LPN) license in the applicable state. Ensure all care and nursing practices are conducted consistent within……
30d+
Viking Engineering + Construction
Health Care Construction Project Manager
Seattle, WA
$105K - $135K (Employer provided)
Easy Apply
*EHS DOCUMENTATION:* Working closely with Project Engineer, Superintendent, Site Safety & Health Officer facilitate the creation, distribution, collection, and……
30d+
DESC
2.9
Lead Clinical Supervisor - Night Shift, CDF
Seattle, WA
$98K - $111K (Employer provided)
Easy Apply
Ability to drive an agency or personal vehicle for work-related duties; valid Washington State driver’s license and insurable driving record required.…
30d+
Archer Mechanical & Maintenance
3.9
Lead BIM/Revit Modeler - Mechanical Piping & Plumbing
Salt Lake City, UT
$65K - $100K (Employer provided)
Easy Apply
_Archer Mechanical specializes in sustainable mechanical and plumbing systems, providing a design-build, design-assist, new construction, additions, remodels,……
30d+
Confidential
Certified Registered Nurse Anesthetist (CRNA)
Addison, TX
Easy Apply
Exposure to anesthetic agents, bloodborne pathogens, and clinical environments. Maintain compliance with CMS, TJC, OSHA, and state nursing board regulations.…
10d
Eagleview Dental
Registered Dental Hygienist--Full-Time or Part-Time
Prairie du Sac, WI
$64K - $116K (Glassdoor est.)
Easy Apply
Follow practice protocols: quality assurance, biohazards, infection control, charting, referral, implants, periodontal program, caries risk assessment and……
30d+
Confidential
Psychiatrist and Medical Director
Missouri
Easy Apply
Active state medical license in good standing (or eligibility). Complete timely, accurate documentation in accordance with CMS, state, and accreditation……
30d+
Center for Neurosciences
3.1
Physician Assistant
Tucson, AZ
Easy Apply
Other Requirements: Current state physician assistant license. Develops and implements treatment plan by prescribing/dispensing medications and/or injections in……
30d+
Primecare Medical
2.6
Licensed Social Worker / Professional Counselor
Clearfield, PA
$65K - $75K (Employer provided)
Easy Apply
Must hold a Master’s degree or greater in Social Work, Psychology, or related Human Service field with a concentration in clinical course work, training and/or……
17d
OneWell
3.8
RN Case Manager
Bluffton, SC
$37.00 - $41.00 Per Hour (Employer provided)
Easy Apply
Licensure: Valid Registered Nurse (RN) license in South Carolina. Ability to develop and implement individualized care plans based on comprehensive individual……
30d+
Kennebec Behavioral Health
3.8
Clinical Manager of Crisis Residential Unit
Waterville, ME
$33.00 - $37.00 Per Hour (Employer provided)
Easy Apply
Qualifications: *Master’s degree in a related field, active clinical Maine licensure (LCSW, LCPC, LMSW) is preferred but will consider conditionally licensed……
24d
Grace Inspired Living
2.9
Director of Nursing
United States
If hired, I understand that my employment is at-will as permitted under applicable state law. We will consider applicants for this position without regard to……
13d
Modoc Work Activity Center
1.0
CT/X-Ray Technologist (Escape the city to Modoc County)
Alturas, CA
$41.87 - $62.22 Per Hour (Employer provided)
Easy Apply
Additional certifications such as ARRT CT certification or advanced cardiac life support (ACLS) preferred to enhance emergency readiness in a rural facility.…
30d+
Professional Engineering Consultants
3.7
Project Engineer - Municipal Transportation
Oklahoma
Easy Apply
The Project Engineer will be responsible for design on multiple projects, directing and/or leading other design professionals within their discipline, and……
25d
Coos Health & Wellness
3.7
Mental Health Therapist - School Position
Coos Bay, OR
$65K - $76K (Employer provided)
Easy Apply
Qualified Mental Health Professional or eligible; Masters degree in psychology, social work, counseling or other related behavioral health field; or Bachelors’……
30d+
Golden Group Home Services
Quality Assurance Director
South Portland, ME
$75K (Employer provided)
Easy Apply
Conduct regular audits and inspections of group home sites to ensure compliance with state and federal regulations, licensing standards, and internal policies.…
30d+
Children’s Home of Poughkeepsie
3.1
Lead Medical Coordinator - Registered Nurse
Poughkeepsie, NY
$95K - $115K (Employer provided)
Easy Apply
Valid Driver’s license in good standing as determined by the agency. Ensures a teaching program for developing healthy living skills is provided for the youth.…
30d+
Bristol Instruments, Inc.
Senior Operations Planner
Victor, NY
$90K - $110K (Employer provided)
Easy Apply
Facilitate product configurational change timing in the context of supply and demand, timing and technical risk, with inputs defined through our change……
9d
Adaptive Home Health
4.5
Director of Clinical Services (RN) Home Health
Las Vegas, NV
$83K - $113K (Glassdoor est.)
Easy Apply
Lead and develop field clinicians. Know when to intervene directly and when to empower field staff with guidance. This is not a passive “clinical support” role.…
30d+
Life Management Center
3.7
Family Services - OP Mental Health Counselor, Master's Degree Req/License Preferred - Holmes Co.
Holmes Beach, FL
$48K - $64K (Glassdoor est.)
Easy Apply
MINIMUM TRAINING, CREDENTIALS AND EXPERIENCE REQUIRED:* Master’s degree from an accredited university or college with a major in counseling, psychology, social……
30d+
Trio Healthcare
3.0
Travel Director of Nursing
United States
Easy Apply
Must be able to direct, supervise and evaluate work activities of medical, nursing, technical, clerical, service, maintenance, and other personnel.…
24d
South Marin Health & Wellness Center
3.4
Physical Therapist (PT)
Greenbrae, CA
$60.00 - $67.00 Per Hour (Employer provided)
Easy Apply
Current, active, and unrestricted Physical Therapist license in the State of California — required (pending licensure considered).…
30d+
Precision Armament
Director of Compliance
Wellsville, NY
$65K - $90K (Employer provided)
Easy Apply
Valid driver’s license and ability to travel between Company facilities as needed. Overseeing firearm-related compliance, including ATF records, A&D records,……
11d

Ultragenyx

3.4

Executive Director, CMC QA

Novato, CA

$294K - $363K (Employer provided)

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this 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:

ultraimpact – Make a difference for those who need it most

The Executive Director, CMC QA will provide strategic, operational, and technical quality leadership across all Ultragenyx programs inclusive of biologics, small molecule, gene therapy, and ASO. This leader will oversee CMC QA responsibilities spanning program QA and CMO QA for starting materials, drug substance, and drug product, ensuring phase-appropriate and commercially robust quality oversight from development through lifecycle management. The role will lead and develop a team of approximately 8–12 quality professionals, partner closely with Technical Operations, Product Development, Supply Chain, Regulatory, and Quality stakeholders, and represent CMC QA in governance forums, inspections, regulatory submissions, and external partner interactions.

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:

Set and execute the CMC QA vision, strategy, operating model, and priorities for External Operations across all Ultragenyx programs and modalities, including starting materials, drug substance, and drug product.

Lead, coach, and develop a high-performing team of approximately 8–12 staff members responsible for program QA and CMO QA oversight; establish clear accountabilities, resource plans, succession plans, and performance expectations.

Ensure external partners operate in compliance with FDA, EMA, ICH, and other applicable global regulatory requirements, Ultragenyx Quality standards, approved regulatory filings, quality agreements, and industry best practices.

Drive proactive, risk-based oversight of external manufacturing quality systems, including deviations, investigations, CAPAs, change controls, complaints, product impact assessments, APR/PQR/APQR, CPV, validation, and tech transfer activities.

Own or oversee quality risk management strategies for external operations, including risk profiles, risk controls, escalation pathways, quality metrics, scorecards, trend reviews, and continuous improvement plans for CMOs and critical suppliers.

Ensure robust CMO and supplier qualification, selection, onboarding, ongoing monitoring, and lifecycle governance in partnership with Technical Operations, Supply Chain, Regulatory, Inspection Management, and Quality Systems.

Lead and/or support health authority inspection readiness, pre-approval inspection readiness, CMO inspection support, due diligence assessments, and responses to inspection observations associated with CMC and external operations.

Provide Quality leadership for regulatory submissions and post-approval commitments, including review of relevant CMC sections for INDs, BLAs, MAAs, amendments, supplements, annual reports, and responses to health authority questions.

Develop, implement, and continuously improve CMC QA policies, SOPs, standards, governance processes, and scalable quality infrastructure to support rare and ultrarare disease product development, commercial supply, and portfolio growth.

Model and reinforce a culture of quality, accountability, collaboration, continuous improvement, and patient focus across internal teams and external partners.

Perform other duties as assigned.

Requirements:

Bachelor's degree in life sciences, engineering, pharmacy, chemistry, biotechnology, or a related discipline; advanced degree (MS, PharmD, PhD, or equivalent) preferred.

Typically 15+ years of progressive experience in pharmaceutical, biotechnology, biologics, gene therapy, small molecule, or related regulated industry, with significant experience in CMC Quality Assurance and external manufacturing oversight.

Typically 10+ years of leadership experience within a Quality organization in a FDA/EMA-regulated environment, including experience leading leaders or senior professionals and managing departmental priorities, budgets, and resources.

Demonstrated experience providing quality oversight for CMOs/CDMOs, critical suppliers, and/or outsourced GMP operations across clinical, launch, and commercial lifecycle stages.

Expert knowledge of global GMP requirements and expectations, including FDA, EMA, ICH Q7/Q8/Q9/Q10/Q11/Q12 as applicable, and experience with other regulatory authorities such as MHRA, PMDA, Health Canada, ANVISA, and/or other global agencies.

Strong technical understanding of CMC development and manufacturing across multiple modalities such as biologics, small molecules, oligonucleotides, gene therapy, mRNA, enzymes/proteins, or other advanced/novel therapeutics; direct experience with starting materials, drug substance, and drug product preferred.

Proven ability to lead CMC QA strategy for rapid development, rare disease, ultrarare disease, registration, launch readiness, and commercial operations in a matrixed and/or highly outsourced operating model.

Demonstrated expertise in quality agreements, supplier qualification, deviation/investigation approval, CAPA effectiveness, change control, validation, technology transfer, APQR/PQR, CPV, and quality metrics.

Experience supporting health authority inspections, PAI readiness, regulatory filings, responses to health authority questions, and inspection observation remediation.

Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.

Executive-level communication, influencing, negotiation, and stakeholder-management skills, with the ability to align senior leaders and external partners around pragmatic, compliant, patient-focused solutions.

Demonstrated ability to build, lead, engage, and develop high-performing teams through ambiguity, growth, and organizational change.

Experience with Veeva or other electronic Quality Management Systems preferred; proficiency with Microsoft Word, Excel, PowerPoint, Teams, and Project or equivalent tools required.

Ability to travel up to approximately 20–30% domestically and internationally to Ultragenyx sites, CMOs/CDMOs, suppliers, and regulatory or inspection-related activities, as business needs require.

Physical Demand Requirements:

Primarily office-based role using a computer, phone, and virtual collaboration tools for extended periods.

Ability to work in a hybrid environment and travel to Ultragenyx sites, external manufacturing partners, contract laboratories, supplier sites, and other business locations as needed.

Occasional entry into GMP manufacturing, warehouse, laboratory, or controlled environments may require use of personal protective equipment and adherence to site-specific gowning, safety, and access requirements.
Ability to sit or stand for extended periods and participate in meetings, inspections, walkthroughs, and partner visits.

#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 talentacquisition@ultragenyx.com.

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: talentacquisition@ultragenyx.com.

See company reviews

Base pay range

The minimum salary is $294K and the max salary is $363K.

$294K – $363K/yr (Employer provided)

$329K

/yr Median

Novato, CA

If an employer includes a salary or salary range on their job, we display it as "Employer Provided". If a job has no salary data, Glassdoor displays a "Glassdoor Estimate" if available. To learn more about "Glassdoor Estimates," see our FAQ page.

Working here doesn’t have to be a secret

3.4

Recommend to a friend
Approve of CEO
CEO: Emil Kakkis
154 Ratings

Ultragenyx

3.4

Executive Director, CMC QA

Novato, CA

$294K - $363K (Employer provided)

Ultragenyx

3.4

Executive Director, CMC QA

Novato, CA

$294K - $363K (Employer provided)

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this job description.

Why Join Us?

Be a hero for our rare disease patients

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:

ultraimpact – Make a difference for those who need it most

Work Model:

Responsibilities:

Set and execute the CMC QA vision, strategy, operating model, and priorities for External Operations across all Ultragenyx programs and modalities, including starting materials, drug substance, and drug product.

Lead, coach, and develop a high-performing team of approximately 8–12 staff members responsible for program QA and CMO QA oversight; establish clear accountabilities, resource plans, succession plans, and performance expectations.

Ensure external partners operate in compliance with FDA, EMA, ICH, and other applicable global regulatory requirements, Ultragenyx Quality standards, approved regulatory filings, quality agreements, and industry best practices.

Drive proactive, risk-based oversight of external manufacturing quality systems, including deviations, investigations, CAPAs, change controls, complaints, product impact assessments, APR/PQR/APQR, CPV, validation, and tech transfer activities.

Own or oversee quality risk management strategies for external operations, including risk profiles, risk controls, escalation pathways, quality metrics, scorecards, trend reviews, and continuous improvement plans for CMOs and critical suppliers.

Ensure robust CMO and supplier qualification, selection, onboarding, ongoing monitoring, and lifecycle governance in partnership with Technical Operations, Supply Chain, Regulatory, Inspection Management, and Quality Systems.

Lead and/or support health authority inspection readiness, pre-approval inspection readiness, CMO inspection support, due diligence assessments, and responses to inspection observations associated with CMC and external operations.

Provide Quality leadership for regulatory submissions and post-approval commitments, including review of relevant CMC sections for INDs, BLAs, MAAs, amendments, supplements, annual reports, and responses to health authority questions.

Develop, implement, and continuously improve CMC QA policies, SOPs, standards, governance processes, and scalable quality infrastructure to support rare and ultrarare disease product development, commercial supply, and portfolio growth.

Model and reinforce a culture of quality, accountability, collaboration, continuous improvement, and patient focus across internal teams and external partners.

Perform other duties as assigned.

Requirements:

Bachelor's degree in life sciences, engineering, pharmacy, chemistry, biotechnology, or a related discipline; advanced degree (MS, PharmD, PhD, or equivalent) preferred.

Typically 15+ years of progressive experience in pharmaceutical, biotechnology, biologics, gene therapy, small molecule, or related regulated industry, with significant experience in CMC Quality Assurance and external manufacturing oversight.

Typically 10+ years of leadership experience within a Quality organization in a FDA/EMA-regulated environment, including experience leading leaders or senior professionals and managing departmental priorities, budgets, and resources.

Demonstrated experience providing quality oversight for CMOs/CDMOs, critical suppliers, and/or outsourced GMP operations across clinical, launch, and commercial lifecycle stages.

Expert knowledge of global GMP requirements and expectations, including FDA, EMA, ICH Q7/Q8/Q9/Q10/Q11/Q12 as applicable, and experience with other regulatory authorities such as MHRA, PMDA, Health Canada, ANVISA, and/or other global agencies.

Strong technical understanding of CMC development and manufacturing across multiple modalities such as biologics, small molecules, oligonucleotides, gene therapy, mRNA, enzymes/proteins, or other advanced/novel therapeutics; direct experience with starting materials, drug substance, and drug product preferred.

Proven ability to lead CMC QA strategy for rapid development, rare disease, ultrarare disease, registration, launch readiness, and commercial operations in a matrixed and/or highly outsourced operating model.

Demonstrated expertise in quality agreements, supplier qualification, deviation/investigation approval, CAPA effectiveness, change control, validation, technology transfer, APQR/PQR, CPV, and quality metrics.

Experience supporting health authority inspections, PAI readiness, regulatory filings, responses to health authority questions, and inspection observation remediation.

Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.

Executive-level communication, influencing, negotiation, and stakeholder-management skills, with the ability to align senior leaders and external partners around pragmatic, compliant, patient-focused solutions.

Demonstrated ability to build, lead, engage, and develop high-performing teams through ambiguity, growth, and organizational change.

Experience with Veeva or other electronic Quality Management Systems preferred; proficiency with Microsoft Word, Excel, PowerPoint, Teams, and Project or equivalent tools required.

Ability to travel up to approximately 20–30% domestically and internationally to Ultragenyx sites, CMOs/CDMOs, suppliers, and regulatory or inspection-related activities, as business needs require.

Physical Demand Requirements:

Primarily office-based role using a computer, phone, and virtual collaboration tools for extended periods.

Ability to work in a hybrid environment and travel to Ultragenyx sites, external manufacturing partners, contract laboratories, supplier sites, and other business locations as needed.

Occasional entry into GMP manufacturing, warehouse, laboratory, or controlled environments may require use of personal protective equipment and adherence to site-specific gowning, safety, and access requirements.
Ability to sit or stand for extended periods and participate in meetings, inspections, walkthroughs, and partner visits.

#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

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

See company reviews

Base pay range

The minimum salary is $294K and the max salary is $363K.

$294K – $363K/yr (Employer provided)

$329K

/yr Median

Novato, CA

Working here doesn’t have to be a secret

3.4

Recommend to a friend
Approve of CEO
CEO: Emil Kakkis
154 Ratings

38,592 Risk-Assurance jobs in United States

Position Summary:

Work Model:

Responsibilities:

Requirements:

Physical Demand Requirements:

Base pay range

Working here doesn’t have to be a secret

Position Summary:

Work Model:

Responsibilities:

Requirements:

Physical Demand Requirements:

Base pay range

Working here doesn’t have to be a secret