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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.…
8d
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.…
8d
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.…
24h
Valence Surface Technologies
2.8
Quality Manager
West Springfield, MA
$90K - $110K (Employer provided)
Easy Apply
Provide quality support for customer quality audits, customer source audits, customers’ failure analysis, customer design reviews, and sales visits.…
30d+
Bitus Labs
2.5
Game Product Manager (Chinese Mandarin Speaker)
Irvine, CA
$100K (Employer provided)
Easy Apply
Can read API documentation and technical designs, decompose them into actionable tasks across disciplines (engineering, art, design, QA), and challenge……
30d+
JW Hicks
3.1
Technical Production Manager
Knox, IN
$65K - $90K (Employer provided)
Troubleshoot problems using root cause analysis procedures and implement corrective actions. Competence in interpreting mechanical drawings.…
30d+
National Raisin Company
Grower Relations Manager
Fowler, CA
$95K - $120K (Employer provided)
Easy Apply
Valid California driver’s license and ability to travel extensively within assigned territory. 10 years or more experience in agricultural field operations,……
18d
PMX Industries
3.5
Engineering Manager
Cedar Rapids, IA
$101K - $146K (Glassdoor est.)
Easy Apply
Previous machine design and project management experience required. Maintain and communicate status of proposed and approved capital projects and engineering……
30d+
Shurwest Financial Group
3.4
Product Manager – Annuity and Life Insurance
Scottsdale, AZ
$74K - $117K (Glassdoor est.)
Easy Apply
Organizes, cleans and synthesizes data to develop actionable insights on new product launches and distribution partnerships.…
30d+
Wilkie Sanderson
4.2
Millwork Programmer Engineer (In-Person)
Sauk Rapids, MN
$25.00 - $35.00 Per Hour (Employer provided)
Easy Apply
Minimum of a 2-year degree in engineering, drafting, or a related field, *or 2+ years of relevant experience.*. Millwork engineering: 5 years (Preferred).…
4d
Iowa Aluminum
1.0
Extrusion Manager
Albia, IA
$52K - $78K (Glassdoor est.)
Easy Apply
The Extrusion Manager leads and mentors the production team, monitors equipment performance, troubleshoots process issues, and collaborates with the die shop to……
7d
Ring Container Technologies
Quality and Food Safety Manager
Lebanon, IN
$85K (Employer provided)
Easy Apply
A four-year college degree required; preferably in a related food science, biology or engineering field. To develop and ensure effective implementation of the……
30d+
Feit Electric
2.8
Senior Product Manager
Pico Rivera, CA
$150K - $170K (Employer provided)
Easy Apply
As Senior Product Manager for the Feit Fixture Business Unit, you will own the full product lifecycle for a portfolio spanning multiple product categories,……
30d+
Fluid Imaging Technologies
3.4
Quality and Supply Chain Manager
Scarborough, ME
$100K (Employer provided)
Easy Apply
Establish and monitor key quality metrics (e.g., yield, defects, field performance, customer complaints) and lead corrective and preventive actions (CAPA).…
30d+
U Baron Group
2.9
Quality & Food Safety Systems Manager
Louisville, CO
$75K - $90K (Employer provided)
Easy Apply
Bachelor’s degree in food science, microbiology, biology, chemistry, or related scientific field required. This role will lead and coordinate the development……
30d+
TRS Technologies, Inc.
Quality Manager
State College, PA
$63K - $93K (Employer provided)
Easy Apply
O Supporting design and development in design reviews, risk management, reliability, safety, hazard assessment, validation and qualification methods, and design……
30d+
Fuller Technologies
Senior Proposal Manager , Pyro& Grinding
Allentown, PA
$82K - $99K (Employer provided)
Easy Apply
Knowledge of cement plant design and layout engineering. Prepare technical Proposals for new cement plants and upgrades which includes planning of Proposal……
2d
GP Machining A Division of Spectron LLC
Quality Control Manager
Buellton, CA
$28.00 - $38.00 Per Hour (Employer provided)
Easy Apply
Bachelor’s degree in a related field *or* equivalent technical experience. This leadership role is responsible for daily QC activities, inspection oversight,……
30d+
The Champion GSE
Engineering Manager
Springfield, OH
$100K - $120K (Employer provided)
Easy Apply
The Engineering Manager is responsible for manage and lead all efforts of design, methods, and process engineering in support of customer requirements while……
30d+
OTTO Engineering
3.6
Supervisor, Tool & Die Design
Carpentersville, IL
$45.00 - $52.00 Per Hour (Employer provided)
Design and develop progressive metal stamping tools, trim dies, fixtures, and gages for new and existing products. Occasional travel to customer sites required.…
30d+
Blue Sky Inventors
Quality Assurance Manager
Helena, MT
$25.00 - $30.00 Per Hour (Employer provided)
Easy Apply
Associate or bachelor’s degree in quality, Manufacturing, Engineering, or a related field preferred. Proficiency with Microsoft Office and quality management……
9d
Integrated Steel, Inc
Structural Engineer
Fargo, ND
$100K - $250K (Employer provided)
Easy Apply
Works closely with our production team to help develop improved manufacturing and design processes by studying product requirements; researching, designing,……
24h
METAL TECHNOLOGIES
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Quality Manager
Hillsdale, MI
Easy Apply
Engineering or technical degree or ASQ certification preferred. Utilize benchmarking process for resolving plant issues and to determine plant and industry best……
2d
Rheo Engineering
2.9
Engineering Project Manager
Peoria, IL
$90K - $125K (Employer provided)
Bachelor’s degree in Engineering or a related technical field. Create project proposals — cost estimates, timelines, and technical specifications — using Rheo’s……
24h
Integrated Steel, Inc
Structural Engineer
Grand Forks, ND
$100K - $250K (Employer provided)
Easy Apply
Works closely with our production team to help develop improved manufacturing and design processes by studying product requirements; researching, designing,……
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Advanced Instrumentations, Inc
TECHNICAL MANAGER/ BIOMEDICAL DEVICES
Miami, FL
$70K - $95K (Employer provided)
Easy Apply
Bachelor’s degree in biomedical engineering, electronics, or a related field. Develop and implement technical training programs for staff and clients.…
8d
Confidential
Managing Director of Engineering, Sales & Service
Milwaukee, WI
$100K - $140K (Employer provided)
Easy Apply
Supervise the Service team with repair analysis, programming guidance, and technical support. He or she manages our small team, drives the sales process,……
4d
TreeHouse Foods
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Maintenance Manager
Tonawanda, NY
$98K - $146K (Employer provided)
Strong knowledge of electronics, controls, mechanical and electrical components found in food manufacturing machinery as well as proper safety standards for……
30d
Raumedic
3.5
Technical Sales Manager
Mills River, NC
$78K - $126K (Glassdoor est.)
Easy Apply
Coordination of the market cultivation (independent market observation and competitive analysis) and market development (define new potential customers and……
30d+
PMC Organometallix
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This person will work very closely with the PMC senior process engineer, manage the other PMC process engineer, and coordinate with embedded multi-plant……
30d+

Ultragenyx

3.4

Executive Director, CMC QA

South San Francisco, 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

South San Francisco, 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

South San Francisco, CA

$294K - $363K (Employer provided)

Ultragenyx

3.4

Executive Director, CMC QA

South San Francisco, 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

South San Francisco, 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?

290,510 Quality/Product Manager 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