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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.…
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
Associate Director, Production and Manufacturing Excellence
New Bedford, MA
$192K - $237K (Employer provided)
Bachelor's degree in science, engineering, or related field required. Provide strategic oversight and technical leadership for complex manufacturing……
6d
Sunflare LLC
Lead QA Engineer
Orlando, FL
$85K - $100K (Employer provided)
Easy Apply
Wire automated suites into GCP-based CI/CD (Cloud Build, GitHub Actions, or equivalent) and enforce quality gates at every stage, driving functional, regression……
25d
Tremco
3.3
Process Engineer II
Ashland, OH
$74K (Employer provided)
Easy Apply
Significant experience with equipment troubleshooting and process design. Ability to perform problem analysis utilizing problem-solving methodology.…
12d
Lewis Machine & Tool Company
3.5
Quality Inspector
Eldridge, IA
$21.00 Per Hour (Employer provided)
Easy Apply
The function of the Quality Inspector is to assist in developing and performing quality inspections on standard and routine processes and products according to……
30d+
Avmax
2.9
Director of Quality - Great Falls Montana
Great Falls, MT
$106K - $160K (Glassdoor est.)
Demonstrated capability and competency in field of expertise. Participate in the establishment, organization, and implementation of short and long-term goals,……
30d+
Oceanside Services
HVAC Quality Assurance Technician
Allenhurst, NJ
$40.00 - $50.00 Per Hour (Employer provided)
Easy Apply
Valid driver’s license with a clean driving record. EPA certification required (NATE certification strongly preferred). Up to $10,000 sign‑on bonus.…
30d+
P2S Inc.
4.3
Senior Commissioning Agent
San Jose, CA
$115K - $150K (Employer provided)
Easy Apply
Valid driver’s license and reliable transportation. Degree in engineering, environmental science, architecture, or related field. Ability to travel up to 30%.…
11d
Galvion
2.1
Quality Inspector - First Shift (7a-3p)
Newport, VT
$19.00 - $22.00 Per Hour (Employer provided)
Easy Apply
Work with the Quality Engineer to develop incoming, in-process, and outgoing inspection procedures. The Quality Control Inspector I performs, documents, and……
27d
Markin Tubing
3.6
Quality Manager
Wyoming, NY
$85K - $105K (Employer provided)
Easy Apply
Working knowledge of IATF 16949 and automotive core tools such as Measurement Systems Analysis, Statistical Process Control, Production Part Approval Process,……
5d
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+
Geotechnical & Environmental Services
3.5
CWI - Certified Welding Inspector, Las Vegas
Las Vegas, NV
$35.00 - $60.00 Per Hour (Employer provided)
Valid driver’s license and clean driving record. Ensure safe work practices are followed at all times in the field and in fabrication environments.…
30d+
The Contents Specialists
4.0
Project Manager / Inspector / Estimator
Georgetown, TX
$54K - $60K (Employer provided)
Easy Apply
Teamwork- Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to……
30d+
The Charles River Center
3.5
Quality Assurance Associate - Residential
Needham, MA
$31.25 Per Hour (Employer provided)
Assist residential programs in preparing for DDS licensing, certification, and survey reviews. Identify quality concerns, develop improvement strategies, and……
4d
First Solar
3.7
Reliability Test Technician
Trinity, AL
$23.37 - $32.69 Per Hour (Employer provided)
Easy Apply
Bachelor's degree in a technical discipline (Electrical preferred) with minimum 2 years work experience in a manufacturing or lab environment OR.…
17d
B & F Construction Code Services
2.7
Technical Code Supervisor
Elgin, IL
$95K - $110K (Employer provided)
Easy Apply
Valid, state-issued driver’s license. The ideal candidate has extensive experience in the construction industry in code compliance or design who can provide……
24d
Lifecore Biomedical
3.2
Manufacturing Inspector - 1st Shift
Chaska, MN
$20.75 Per Hour (Employer provided)
Document work and carefully audit documentation before final presentation. 401k plan with company matching contribution. Low cost dental and vision insurance.…
27d
FuelCell Energy
3.0
Quality Engineer - Product (Hybrid Connecticut)
Danbury, CT
$106K - $117K (Employer provided)
Easy Apply
The Quality Engineer is responsible for proactively ensuring the quality of all aspects of the balance of plant for FuelCell Energy Block Systems and the……
17d
St. Xavier Home Care Services
2.7
Quality Assurance (QA) Manager, Supervisor & Specialist–Opioid Treatment Program (OTP /COP)
Forest Hills, NY
$26.00 - $39.00 Per Hour (Employer provided)
Easy Apply
Bachelor's degree required; Master's degree in Healthcare Administration, Public Health, Nursing, Social Work, Psychology, or a related field preferred.…
10d
Keene Automotive
Certified Maryland State Automotive Inspector
Jarrettsville, MD
$35.00 Per Hour (Employer provided)
Easy Apply
 Valid driver's license with a clean driving record. Do you have a valid driver's license? Do you have a clean driving record?  2+ years of experience.…
3d
AWG
3.4
ASVH-Flagstaff - Quality Assurance Nurse (RN or LPN)
Flagstaff, AZ
$79K - $116K (Glassdoor est.)
Easy Apply
Current Arizona RN or LPN license. Conduct audits, data analysis, and CASPER report reviews to develop and track Quality Assurance Performance Improvement Plans……
30d+
S&M Automotive Service
AUTOMOTIVE TECHNICIAN / VIRGINIA STATE INSPECTOR
Mechanicsville, VA
$75K - $100K (Employer provided)
Easy Apply
We are a busy, well-established independent automotive repair shop seeking an experienced Automotive Technician with a current Virginia State Inspection License……
30d+
Advanced Motion Controls
2.8
QUALITY COMPONENT ENGINEER
Camarillo, CA
$80K - $110K (Employer provided)
Serve as the technical lead for component quality across the product lifecycle—from selection and qualification through design changes and field performance.…
30d+
Minerals Technologies
3.1
Quality Assurance Manager
Adams, MA
$71K - $113K (Glassdoor est.)
Responsible for determining if products conform to the corporate goal of consistent product quality and for maintaining and assuring completion of quality goals……
30d+
Miller Industries
3.3
Quality Engineer
Hermitage, PA
$57K - $77K (Glassdoor est.)
Ability to read and understand engineering drawings, standards, specifications, and other technical documents. AD&D, Disability & Basic Life – no cost to you!…
30d+
Industrial Testing Laboratory Systems
Non-Destructive Testing Technician - Lvl. II
Pittsburgh, PA
$24.50 - $32.00 Per Hour (Employer provided)
Easy Apply
Devlopment of NDE procedures, technical data sheets and addendums. Foster positive customer relationships and generate new leads. Up to 4 weeks PTO.…
30d+
R.E. Staite Engineering
4.0
Construction Quality Control Manager (CQC) -
San Diego, CA
$80K - $100K (Employer provided)
Easy Apply
Must have a valid U.S. driver's license, pass a drug test, and be able to pass a federal background investigation. 5 years experience as a CQCM.…
3d
Groupe Bel
3.8
Process Project Engineer
Nampa, ID
$92K - $127K (Glassdoor est.)
Ensure completion of the contractor safety and GMP training for all people brought on-site to work on projects and enforce these standards with contractors.…
30d+
Novolex
2.9
Process Engineer
Yakima, WA
$100K - $120K (Employer provided)
Provide technical inputs for incident investigation, root cause analysis and corrective action. Strong mechanical, electrical and manufacturing process skills/……
17d

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

34,873 Performance and quality 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