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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.…
2d
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.…
2d
Ultragenyx
3.4
Supervisor, GMP Facilities
Bedford, MA
$107K - $133K (Employer provided)
Associate or bachelor's degree in engineering, Facilities Management, or a related field (or equivalent combination of education and experience).…
29d
Ruston Paving
4.7
Diesel Mechanic - $8,000 SIGNING BONUS
Syracuse, NY
$27.00 - $38.00 Per Hour (Employer provided)
Valid and appropriate in-state driver’s license (or the ability to obtain said license) is required. Ability to perform job requirements in adverse field and……
30d+
Schreiber Foods
3.8
Electronic Technician [PH]
Monett, MO
$31.50 - $41.99 Per Hour (Employer provided)
Predictive tool and technique examples include but are not limited to: Ultrasonic, Infrared, oil analysis, various vibration analysis tools, and laser alignment……
24d
Crane Aerospace & Electronics
2.7
APQP Quality Engineer
Elyria, OH
$71K - $89K (Glassdoor est.)
Review statistical studies, regulatory standards and trends in the field of quality control. Bachelor of Science degree in Quality, Mechanical Engineering or……
30d+
Prisma Health
3.4
Radiation Therapist
Greenville, SC
$66K - $81K (Glassdoor est.)
Ensures all regulatory, state, and accrediting agency standards and requirements are maintained. Prepares and administers contrast agents as prescribed.…
30d+
Cypress At Home
2.0
Occupational Therapist - PRN
Fort Myers, FL
$59K - $85K (Glassdoor est.)
Easy Apply
Assists the physician in evaluating level of function, helps develop the plan of care (revising as necessary), advises and consults with the family and other……
30d
Integra Aviation Academy
3.0
Rotor Wing Pilot - Houston / San Antonio Float Pilot - 46k Retention Bonus
Pearland, TX
$93K (Employer provided)
Easy Apply
Participate in the pre-flight risk assessment process. The Pilot-in-Command has command of, and the responsibility for the medical crew members, passengers,……
30d+
Cirrus Aircraft
3.6
Measurement Specialist 2 - $5,000.00 Signing Bonus
Duluth, MN
$28.65 - $42.97 Per Hour (Employer provided)
Proficiency in reading engineering drawings, blueprints, and technical documentation. This role involves inspecting, testing, and verifying products to ensure……
18d
NATIONAL DIZZY BALANCE CENTER
1.6
Physical Medicine & Rehabilitation Provider
Minneapolis, MN
$200K - $230K (Employer provided)
Easy Apply
Attend seminars and training as required by license and NDBC. The commitment to excellence and patient relationships sets NDBC as a standard in the field,……
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+
Oak Medical
4.2
Psychiatric Mental Health Nurse Practitioner
Madison, WI
$111K - $143K (Glassdoor est.)
Easy Apply
The Psychiatric Mental Health Nurse Practitioner (PMH-NP) functions under the clinical supervision of licensed physicians, provides diagnostic and therapeutic……
30d+
PRIORITY AMBULANCE CALIFORNIA LLC
CQI Specialist
San Bernardino, CA
$61K - $75K (Employer provided)
Valid driver's license with acceptable driving record. The Clinical CQI Specialist conducts patient care report (PCR) audits, investigates clinical and……
19d
Northern Engraving
2.7
Sales Account Manager
Sparta, WI
Participate in new project cooperation throughout the entire process; support engineering design, prototype validation, mass production, and other phases;……
30d+
Thoma-Sea Marine Constructors, LLC
QC Inspector
Houma, LA
$18.00 - $23.00 Per Hour (Employer provided)
Easy Apply
Must obtain majority of own inspection tools. Hands on experience in inspection of marine engine components, deck machinery (winches, cranes), pumps, valves,……
30d+
Hydrox Laboratories
2.7
Engineering Change Control Manager
Elgin, IL
$90K - $110K (Employer provided)
Easy Apply
Lead the end‑to‑end change control process, including intake, risk assessment, impact analysis, approval routing, implementation oversight, and closure.…
4d
Inpria
4.7
Senior Process Engineer – Precursor Manufacturing
Corvallis, OR
$73K - $104K (Glassdoor est.)
Easy Apply
The Senior Process Engineer – Precursor Manufacturing will oversee day-to-day production activities, own manufacturing scale-up and production execution, and……
30d+
Mission Cancer + Blood
2.8
Physician Aligned APP (ARNP or PA)
Des Moines, IA
$91K - $170K (Glassdoor est.)
Easy Apply
Local Travel:* Within the state of Iowa. Perform complete assessment of the patient including vital signs, patient history, review of systems, and physical and……
30d+
SpectronRx
3.0
Manufacturing Specialist
Bunker Hill, IN
$25.00 - $31.00 Per Hour (Employer provided)
Easy Apply
A bachelor’s degree in chemistry, biochemistry, chemical engineering, or a related field preferred. Valid Indiana driver’s license.…
5d
Capital Health
3.1
Assistant Nurse Manager - NICU - Hopewell - Full Time - DAYS
Pennington, NJ
$47.68 - $63.56 Per Hour (Employer provided)
Monitors clinical management of patient care delivery area to produce quality patient care with optimal outcomes. Serves as a clinical resource to staff.…
30d+
McGough Construction
4.2
Superintendent, Healthcare
Raleigh, NC
$75K - $129K (Glassdoor est.)
The Superintendent works diligently to meet all goals set for the specific project and manage all field operational duties. High school diploma or GED required.…
30d+
Helitech
3.8
Experienced Gutter Installer
Caseyville, IL
$25.00 - $35.00 Per Hour (Employer provided)
Easy Apply
Valid driver's license and clean driving record. Minimum of 3 years of experience in gutter installation or related field. Ability to Pass a Background Check.…
30d+
Tecomet
3.0
Quality Engineer I
Warsaw, IN
$70K - $78K (Employer provided)
Easy Apply
Bachelor's Degree in Engineer or related field. Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.…
22d
Mountaire Farms
3.5
Cone Debone Supervisor
Millsboro, DE
Following prescribed Human Resources/Safety policies and procedures, completing Kronos and Oracle HCM time off requests on a timely basis, completing safety and……
30d+
GEM Technology
4.0
Structural Engineer
Oak Ridge, TN
$150K - $170K (Employer provided)
Easy Apply
Advanced Degree in Civil or Mechanical Engineering or related technical field. Present preliminary and final structural design and analysis to the International……
30d+
Fagron
3.7
Aseptic Process Validation Specialist
Wichita, KS
$60K - $75K (Employer provided)
The role involves coordinating cross-functional teams, documenting processes, analyzing results, and driving continuous improvement initiatives in aseptic……
24h
McPherson Concrete Products
4.0
Quality Control Inspector
McPherson, KS
$45K - $60K (Employer provided)
Easy Apply
Perform field and lab testing of concrete (slump, air content, temp, compressive strength, etc.). Entry Level/non-management position traveling to remote……
30d+
NeuroPsychiatric Hospitals
3.0
RN Supervisor
Bremen, IN
$60K - $78K (Glassdoor est.)
Must be a Registered Nurse (RN) in the state of Indiana. The Nursing Supervisor (RN), under the direction of the DON, will help plan, direct, and evaluate total……
12d
AuST Manufacturing
3.9
Director of Technical Operations
West Valley City, UT
$96K - $146K (Glassdoor est.)
Easy Apply
You have personally designed and built automated manufacturing equipment — not supervised a vendor who built it, but done the mechanical design, electrical……
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

Are you open to new opportunities?

23,322 Deviation management 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