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.…
18d
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.…
18d
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……
7d
GroundWork Renewables
4.8
Laboratory Operations Manager
Albuquerque, NM
$125K - $127K (Employer provided)
Easy Apply
Education: Bachelor’s degree in engineering, operations management, quality management, or a related field required. Master’s degree is a plus.…
7d
Orion Castings
Quality Engineer
Grafton, WI
Work with customers, employees, contractors, and outsourcing firms to develop product requirements as needed. Identify areas for Quality Control improvement and……
24h
Unipres
3.4
Quality Section Manager (Night Shift)
Smyrna, TN
$63K - $94K (Employer provided)
Easy Apply
Other field of study considered with relevant experience. Inspect all design changes and new model trials for conformation to quality standards.…
24h
Crane Worldwide Logistics
3.3
Quality & Inventory Lead - (Mon - Thur) - Second Shift
McCook, IL
$55K - $77K (Glassdoor est.)
Directs and leads the work of any personnel assigned to the quality audits and/or inventory counts by the Warehouse Supervisors Provides daily written and……
30d+
AGC/ GarKenyon
Quality Engineer - II
Meriden, CT
Easy Apply
O Associate’s or Bachelor's degree in related field (e.g., Business Administration, Quality Assurance, or Engineering) is preferred.…
30d+
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……
25d
Smart Sand
3.3
ISO Specialist
Tomah, WI
$60K (Employer provided)
Easy Apply
High school diploma required, Associates in a related field preferred. Works with Process Area Managers to develop user-friendly forms to document measurable……
13d
Elite RF LLC
Manufacturing Quality Engineer (Electronics Manufacturing)
Hanover Park, IL
$75K - $85K (Employer provided)
Easy Apply
Perform *incoming inspection* of machined and fabricated metal parts using mechanical and SolidWorks drawings.…
30d+
The Outdoor Group
2.4
Quality Control Supervisor
West Henrietta, NY
$25.00 - $40.00 Per Hour (Employer provided)
Easy Apply
Associate degree in a related field or an equivalent combination of education and experience preferred. Ability to read engineering drawings and use precision……
14d
Critical Process Systems
3.8
Quality Technician 1st Shift (5:00AM-3:30AM)
Colchester, VT
$20.00 - $24.00 Per Hour (Employer provided)
Easy Apply
High school diploma or equivalent; an associate degree or vocational training in Quality Assurance, Engineering, or a related field is preferred.…
30d+
Critical Process Systems
3.8
Quality Technician 2nd Shift (3:30PM-2:00AM)
Colchester, VT
$20.00 - $24.00 Per Hour (Employer provided)
Easy Apply
High school diploma or equivalent; an associate degree or vocational training in Quality Assurance, Engineering, or a related field is preferred.…
28d
WORLDPAC
2.7
Assistant Branch Operations Manager
Augusta, ME
$51K - $55K (Employer provided)
Meet all applicable state/province-specific driver’s license requirements prior to driving a company vehicle to perform delivery duties.…
12d
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,……
6d
Applied Laser Technologies
4.1
Quality Manager
Schofield, WI
$72K - $103K (Glassdoor est.)
Easy Apply
Provides hands-on technical quality support by evaluating parts, drawings, specifications, manufacturing methods, inspection results, customer concerns, and……
30d+
CLEARWATER ENGINEERING INC.
Quality Assurance Inspector
Derby, KS
Easy Apply
Associate degree in a technical field or equivalent experience. 4+ years’ experience in precision mechanical and/or electrical components inspection.…
30d+
Gamco
3.5
Production Manager Assistant- In Manufacturing (Bilingual Chinese Speaking)
Flushing, NY
$18.00 - $22.00 Per Hour (Employer provided)
Easy Apply
*Bachelor’s degree *in industrial engineering, Manufacturing, Operations Management, or a related field is a Plus. Bilingual Chinese/English is Required.…
30d+
Virginia-Georgia Transformer
2.2
Quality Technician
Troutville, VA
$42K - $56K (Glassdoor est.)
Easy Apply
Provide technical support to the field service function. Minimum two years Associates degree in related field. Support special components and systems testing.…
12d
SRM Concrete
2.6
Divisional Quality Control Manager
Dallas, TX
$84K - $140K (Glassdoor est.)
ACI certification preferred and/or the ability to obtain ACI certifications. Collaborate with production, operations, sales, and technical services teams to……
30d+
Hudson Valley Lighting
1.7
Quality Control Supervisor
Wappingers Falls, NY
$25.00 - $26.44 Per Hour (Employer provided)
Easy Apply
This role is responsible for overseeing daily QC operations while actively contributing to the assembly, rework, and repair of lighting fixtures and displays in……
30d+
Stay Fresh Foods
FSQA Lead Technician First Shift
Lincoln, NE
$20.00 Per Hour (Employer provided)
Easy Apply
The Quality Assurance Lead must have, or achieve within a reasonable timeframe, certification in SQF, HAACP, and GMP programs.…
26d
Critical Process Systems
3.8
Environmental Health and Safety Assistant Manager
Boise, ID
$90K (Employer provided)
Easy Apply
Assists in design and implementation of safety programs to prevent or correct unsafe working conditions, utilizing knowledge of engineering technology,……
24h
RWD Consulting
2.8
Quality Control Manager
Falls Church, VA
$120K - $140K (Employer provided)
Easy Apply
Bachelor’s degree in a related field. In this pivotal role, you will oversee the implementation and maintenance of quality systems, ensuring compliance with……
19d
Petainer
3.3
Quality Assurance, Compliance & EHS Manager
Mount Pleasant, TN
$80K (Employer provided)
Easy Apply
Lead certification audits, surveillance audits, and recertification activities, from both certification bodies and customers.…
30d+
Massimo Zanetti Beverage
3.0
Quality Assurance Technician
Suffolk, VA
$21.00 - $31.00 Per Hour (Employer provided)
Maintains laboratory inventory of tools, supplies, chemicals, and assure all measurement analysis equipment is functional as well as calibrated on a routine……
30d+
Critical Process Systems
3.8
Quality Technician 3rd Shift (9:00PM-5:00AM)
Tolleson, AZ
$20.00 - $24.00 Per Hour (Employer provided)
Easy Apply
High school diploma or equivalent; an associate degree or vocational training in Quality Assurance, Engineering, or a related field is preferred.…
28d
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.…
11d
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+

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

330,485 Assistant Manager, 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