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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.…
15d
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.…
15d
Piper Aircraft
3.8
Sr Manager, Aircraft Certification & ODA Administrator
Vero Beach, FL
$92K - $131K (Glassdoor est.)
Easy Apply
Requires a Bachelors degree in an engineering or technical discipline (preferably Aeronautical or Aerospace) and minimum of eight (8) years aircraft……
30d+
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……
22d
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.…
8d
BryMak & Associates
3.0
Quality Control Manager/Site Safety and Health Officer (Dual-Hatted) - 2 yeas experience required
Bethesda, MD
$80K - $90K (Employer provided)
Easy Apply
Education: Bachelor’s degree in engineering, construction management, occupational safety, facility management, or a related field (or equivalent experience).…
23d
Confidential
Quality and Regulatory Manager
Dayton, OH
$60K - $80K (Employer provided)
Easy Apply
Assist in the develop of inspection methods, design gauges and fixtures to improve inspection. Bachelors degree in Engineering or related field with experience.…
7d
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+
Celebrating Life Community Health Center
4.6
Director of Clinical Quality (Onsite)
Mission Viejo, CA
$160K - $180K (Employer provided)
Easy Apply
Ensure compliance with federal, state, accreditation, and health plan requirements by developing policies, monitoring quality metrics, and leading clinical……
2d
Confidential
Quality Assurance Manager
Chicago, IL
$70K (Employer provided)
Easy Apply
Strong analysis skills with the ability to interpret data and develop strategic solutions for continous improvement. Food industry: 5 years (Required).…
30d+
Ritter Foods, LLC
Food Safety and Quality Control Manager
Philadelphia, PA
Easy Apply
Bachelor's degree in Food Science, Microbiology, or a related field. Collaborate with certification bodies and internal teams to address SQF-related matters.…
30d+
GNS America
3.3
Quality Manager
Holland, MI
$59K - $91K (Glassdoor est.)
Easy Apply
Familiarity with the tools, concepts and methodologies of quality management. Our in-house tool & die capabilities provide full design, simulation, and build……
30d+
Stay Fresh Foods
FSQA Manager
Lincoln, NE
Easy Apply
Maintain workflow by setting process variables, monitoring steps of the process; observing equipment and control points; monitoring resources and personnel;……
30d+
Pivot Staffing (OH)
1.0
Bilingual Spanish /English Afternoon Quality Control Supervisor
Sterling Heights, MI
$21.00 Per Hour (Employer provided)
Easy Apply
Demonstrated ability to perform detailed analysis using data collection tools and generate comprehensive reports. Pay: From $21.00 per hour.…
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……
11d
Gulf Stream Coach
2.0
Quality Assurance Manager
Nappanee, IN
$57K - $92K (Glassdoor est.)
Easy Apply
Provide a wide variety of interior/exterior repairs to units, i.e.; diagnose, inspect, adjust and perform repairs and parts/component replacements on units in a……
24h
Verify
2.9
Lead Quality Engineer
Cincinnati, OH
$55.00 - $60.00 Per Hour (Employer provided)
Easy Apply
This person will also *train and develop additional QE resources* using a structured *train‑the‑trainer model*. Completion of master specification requirements.…
30d+
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……
16d
SensorLink Corporation
Quality Manager - Manufacturing
Ferndale, WA
$85K - $105K (Employer provided)
Easy Apply
Bachelor’s degree in engineering, manufacturing, quality, or related technical field (or equivalent experience). Occasional lifting of up to 25 pounds.…
3d
SRM Concrete
2.6
Divisional Quality Control Manager
Dallas, TX
ACI certification preferred and/or the ability to obtain ACI certifications. Collaborate with production, operations, sales, and technical services teams to……
30d+
Perdue
3.3
Food Safety & Quality Assurance Manager - $10K Sign-On Bonus
Milford, DE
$101K - $126K (Employer provided)
Easy Apply
As the plant authority on food safety and quality, you will guide, develop, and inspire a high performing FSQA team while partnering with plant leadership to……
4d
St. Bernard Hospital and Health Care Center
3.1
Risk and Quality Compliance Manager (RN)
Chicago, IL
$80K - $90K (Employer provided)
Easy Apply
Current Registered Nurse (RN) license in the State of Illinois. Bachelor’s degree in Nursing (BSN) or other clinical healthcare field.…
24h
Jefferson Regional Medical Center (Arkansas)
3.7
Registered Nurse (RN) Director Quality Assurance
White Hall, AR
$68K - $105K (Glassdoor est.)
Easy Apply
Applicants should have a current state or compact state RN license and possess an bachelor’s degree from an accredited nursing school. What we're looking for.…
22d
American Paper Bag
Quality Manager
Reno, NV
$110K - $130K (Employer provided)
Easy Apply
Lead and develop the quality team, including assigning priorities, evaluating performance, and building technical capability.…
25d
The Greenbrier Companies
3.5
QA Manager
Tacoma, WA
$65K - $85K (Employer provided)
Degree in mechanical or industrial engineering or equivalent, or five years experience in quality assurance, including two years in a Quality Manager role.…
28d
Northeast Foods
Corporate Food Safety Manager
Baltimore, MD
$75K - $85K (Employer provided)
Easy Apply
Collaborate with cross-functional teams to establish quality control procedures, perform root cause analysis, and implement corrective and preventive actions (……
23d
Foamtec International
3.0
Quality Manager
Waco, TX
$67K - $104K (Glassdoor est.)
Easy Apply
5+ years experience in regulatory affairs, product development, or product manufacturing in a Management capacity. Oversee MRB (Material Review Board) process.…
30d+
The Middlesex Corporation
3.3
Quality Control Manager
Boston, MA
$72K - $105K (Glassdoor est.)
Easy Apply
Provide ongoing and regular quality control related technical input for construction planning, interpretation of design, development of efficient construction……
30d+
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,……
3d
Confidential
Quality Assurance Manager
Leominster, MA
$90K - $95K (Employer provided)
Easy Apply
Bachelor's degree in Food Science, Microbiology, Chemistry, Biology, or a related field preferred. Manage food safety programs, sanitation verification, pest……
11d

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

9,330 Sr. Quality 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