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.…
14d
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.…
14d
Ultragenyx
3.4
Senior Manager, CMC QA
South San Francisco, CA
$175K - $216K (Employer provided)
Bachelor's degree in a science or related technical field with no less than 7 years relevant industry experience.…
6d
State of Washington
3.4
Physician 3-Gender Affirming Care- CE69-HQ
Tumwater, WA
$209K - $281K (Employer provided)
Unrestricted license to practice medicine in Washington State. Unrestricted DEA license with waiver to prescribe buprenorphine for opioid use disorder.…
30d+
State of Washington
3.4
Physician 3 - CRCC
Connell, WA
$246K - $331K (Employer provided)
Unrestricted license to practice medicine in Washington State. Unrestricted DEA license with waiver to prescribe buprenorphine for opioid use disorder.…
30d+
Monarch Healthcare Management
4.0
Director of Nursing (DON)
Rush City, MN
$90K - $100K (Employer provided)
Easy Apply
Ensure compliance with state and federal regulations, Nurse Practice Act, and Residents’ Bill of Rights while promoting autonomy, confidentiality, and……
22d
StoryPoint
4.2
QMA - Insulin Certified
Washington, IN
$20.00 - $21.00 Per Hour (Employer provided)
Easy Apply
Position: Must be a licensed Insulin Certified Qualified Medication Aide. Make sure work areas (medication and treatment cart, medication room, nurse’s station,……
15d
Monarch Healthcare Management
4.0
Nursing Home Administrator
Richfield, MN
$105K - $120K (Employer provided)
Easy Apply
Bachelor's degree in Healthcare Administration or a related field. Lead the facility through state and federal surveys while supporting timely corrective action……
30d+
PriorityPet Urgent Care of Rochester
Veterinarian, Partner & Equity Owner
Rochester, MN
$120K - $220K (Employer provided)
Easy Apply
Doctorate in Veterinary Medicine (or equivalent) from an accredited university, and an active veterinary state license. Student Loan and Relocation Assistance.…
30d+
Confidential
Biorepository Operations Director
Arlington, VA
Easy Apply
Bachelor’s degree in science, health science or another relevant field required. Potential exposure to bodily fluids, blood borne pathogens, electrical,……
30d+
McDonald's
3.6
Spec. Ed. Self Contained Teacher
Phoenix, AZ
$1,140 (Employer provided)
Assesses student performance to determine whether or not the objectives are being achieved, and refers students for specialized help when necessary.…
29d
Woodloch Pines Resort
3.9
Line Cook
Hawley, PA
$33K - $42K (Glassdoor est.)
Proper date, labeling and working in compliance of Pennsylvania state food code. GENERAL PURPOSE OF JOB: Responsible for the preparation of all hot food for AP……
30d+
Healthcare Therapy Services
4.2
Licensed Physical Therapist – PT – Full Time
Grand Rapids, MI
Easy Apply
Applicants for this position must hold a state Physical Therapist license. This PT will conduct evaluations, progress notes, recerts and discharges and provide……
30d+
Woodhouse Day Spa
2.7
Experienced Licensed Massage Therapist (LMT)
Olathe, KS
$50K - $75K (Employer provided)
Easy Apply
Active Leawood, KS massage license. Ensure each guest is happy, cared for, and demonstrate exceptional customer service to exceed our guests’ expectations.…
17d
BAE Systems USA
3.7
Senior Electrical Engineer
Hill AFB, UT
$119K - $201K (Employer provided)
This engineer will assist in acquiring, testing, and integrating guidance equipment for the Sentinel weapon system, collaborating with the government customer……
30d+
Mondelēz International
3.8
Driver CDL
Williston, VT
$33.00 Per Hour (Employer provided)
Must have a CDL-Class A license and have at least one year of proven safe driving experience. (Adjusted to the license requested to the role).…
30d+
PriorityPet Urgent Care of Saratoga Springs
Veterinarian, Partner & Equity Owner
Saratoga Springs, NY
$120K - $220K (Employer provided)
Easy Apply
Doctorate in Veterinary Medicine (or equivalent) from an accredited university, and an active veterinary state license. Student Loan and Relocation Assistance.…
30d+
Senior Helpers
3.4
Caregiver (PT) Urgently Hiring!
Corvallis, OR
$17.50 Per Hour (Employer provided)
Easy Apply
*Valid driver's license with no serious driving violations and current auto insurance*. Ability to read, write, and speak English at an average adult level.…
30d+
International Waxes, Inc.
Environmental Manager
Smethport, PA
Easy Apply
The individual will accompany all state and federal inspectors during site environmental inspections. Be proficient with project planning tools, technical……
30d+
Senior Helpers
3.4
Caregiver (P/T) Urgently Hiring!
Dallas, OR
$17.50 - $18.50 Per Hour (Employer provided)
Easy Apply
Valid driver's license with no serious driving violations and current auto insurance. Ability to read, write, and speak English at an average adult level.…
30d+
Yield Technology Service
Agricultural Equipment Service Technician (2 years exp)
Carrollton, MO
$31.00 - $40.00 Per Hour (Employer provided)
Easy Apply
Must have a valid driver's license. Advanced knowledge of mechanical, electrical, and hydraulic systems used in the repair of agricultural equipment.…
30d+
Murphy Dental
RDH Dental Hygienist
Fort Collins, CO
$50.00 - $57.00 Per Hour (Employer provided)
Easy Apply
Always working to gain new knowledge and technology through continuing education and state-of-the-art dental equipment. Tuesday and Wednesday: 8 AM to 5 PM.…
30d+
Monarch Healthcare Management
4.0
Director of Nursing (DON)
Gaylord, MN
$95K - $115K (Employer provided)
Easy Apply
Ensure compliance with state and federal regulations, Nurse Practice Act, and Residents’ Bill of Rights while promoting autonomy, confidentiality, and……
30d+
Monarch Healthcare Management
4.0
Culinary Service Cook
Lake Crystal, MN
$18.00 - $22.00 Per Hour (Employer provided)
Easy Apply
The Culinary Service Cook is accountable to prepare, serve, and/or be responsible for the preparation of foods for residents, guests, and employees.…
30d+
Monarch Healthcare Management
4.0
Registered Nurse (RN)
Gaylord, MN
$36.00 - $41.00 Per Hour (Employer provided)
Easy Apply
The role conducts comprehensive health assessments, develops individualized care plans, and oversees the implementation of nursing interventions while……
30d+
Cox Fleet
3.4
Shop Trailer Mechanic $3000 New Hire Bonus
Florida, NY
$15.00 - $25.00 Per Hour (Employer provided)
Easy Apply
The Shop Trailer Technician II will be responsible for performing certified DOT inspections, Preventative Maintenance inspections, light repairs, and other……
24h
Mondelēz International
3.8
Driver CDL
Haverhill, MA
$29.80 Per Hour (Employer provided)
Must have a CDL-Class A license and have at least one years of proven safe driving experience. Minimum of one year of safe driving experience with no serious……
30d+
Powell Industries
4.4
Senior Mechanical BIM Engineer - Northlake, IL
Northlake, IL
$77K - $98K (Glassdoor est.)
You will use computer-aided design (Autodesk Revit) and other specialized software tools to coordinate & generate detailed layout plans, schematics, schedules……
30d+
Commercial Roofing & Waterproofing Hawaii, Inc.
Field Lead - Service Department
Waipahu, HI
$29.00 - $35.00 Per Hour (Employer provided)
Easy Apply
Complete assigned jobs completely and properly with your helper(s) in the field. Recognize roofing issues, communicate with repair estimators and assist with……
24h
Monarch Healthcare Management
4.0
Culinary Service Cook
Mapleton, MN
$18.00 - $22.00 Per Hour (Employer provided)
Easy Apply
The Culinary Service Cook is accountable to prepare, serve, and/or be responsible for the preparation of foods for residents, guests, and employees.…
30d+

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

59,309 Always changing 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