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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.…
14d
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.…
14d
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.…
6d
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+
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+
Saban Community Clinic
3.7
MD - Associate Medical Director
Los Angeles, CA
$267K - $318K (Employer provided)
Easy Apply
Work with CMO to develop/review and oversight adherence to clinical care protocols and chronic disease management guidelines. $15,000 Sign on Bonus.…
7d
Cascade Living Group
3.3
Temporary Associate Wellness Director LPN
Bend, OR
$38.00 - $40.00 Per Hour (Employer provided)
Easy Apply
Maintains a current state license as a professional Licensed Practical Nurse (LPN). As a Temporary Associate Wellness Director LPN at Cascades of Bend you’ll……
28d
Confidential
Sales & Quality Manager – Ready Mix / Concrete
Mount Vernon, OH
$57K - $130K (Employer provided)
Easy Apply
The right candidate will be expected to be *boots on the ground*, actively engaged in daily sales operations, customer relationships, and field support.…
30d+
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+
Westchester Plastics
2.0
Quality Assurance Manager
Nesquehoning, PA
$85K - $100K (Employer provided)
Easy Apply
Maintain appropriate ISO certification requirements and coordinate registration activities as management representative. Ability to communicate with customers.…
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
Providence at Home with Compassus
2.7
Hospice Medical Director/Associate Medical Director
Seattle, WA
$210K - $230K (Employer provided)
Easy Apply
An active and unencumbered Medical Doctor (MD) or Doctor of Osteopathic Medicine (DO) license within the state of employment.…
16d
Diversified Service Contracting
SSHO/QM (Site Safety and Health Officer/ Quality Manager).
Washington, DC
$85K - $87K (Employer provided)
Easy Apply
Completed the OSHA 30-hour construction safety class or equivalent within the last three years. Oversee the product manufacturing process to ensure quality.…
30d+
GoHealth Urgent Care
3.2
Regional Associate Medical Director | Physician Leader | - Sign on Bonus- $25,000
Des Peres, MO
Easy Apply
Minimum 2 years of clinical leadership or administrative experience in urgent care, emergency medicine, or related field (required). $25K Sign-On Bonus.…
21d
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.…
7d
Preferred IPA
3.5
Quality Improvement Manager
Glendale, CA
$70K - $75K (Employer provided)
Easy Apply
Have valid driver license and proof of insurance. Assist quality managers to develop tools to measure quality improvement performance and to establish goals for……
30d+
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. Operations management: 10 years (Required).…
3d
Camarena Health
4.1
Associate Medical Director
Madera, CA
$300K - $350K (Employer provided)
Easy Apply
Current, unrestricted medical license in the State of practice. This position combines direct patient care with clinical leadership, ensuring delivery of high-……
30d+
Watts Healthcare
2.7
Director of Quality
Los Angeles, CA
$120K - $145K (Employer provided)
Easy Apply
The Director of Quality collaborates closely with executive leadership, medical leadership, operations, population health, and clinical teams to develop and……
30d+
Sitka Counseling and Prevention Services
4.0
Associate Clinical Director
Sitka, AK
$70K - $100K (Employer provided)
Easy Apply
Master’s degree in a behavioral health field (social work, psychology, counseling); Alaska CDC II certification or ability of obtain within one year; LPC, MAC,……
30d+
Dental Associates Minnesota
2.5
Director of Quality Initiatives & Compliance
Savage, MN
$120K - $140K (Employer provided)
Easy Apply
Active Minnesota Dental Hygiene License or Dental Therapist license required. Reporting to the Dental Director, this leadership role is ideal for a licensed……
30d+
Tutco-Farnam
4.1
Quality Manager
Melrose Park, IL
$87K - $125K (Glassdoor est.)
Easy Apply
Establish a good working relationship with DRC’s customers to address and resolve returned goods, answer technical questions, and handle warranty claims.…
30d+
ERSG
3.5
Quality Manager - Renewable Energy
Oregon
$42.00 - $50.00 Per Hour (Employer provided)
Easy Apply
This role is responsible for verifying contractor compliance with project specifications, codes, and contractual requirements, and for driving continuous……
30d+
Boutique Recruiting
4.6
Lab Manager
Livermore, CA
$30.00 - $38.00 Per Hour (Employer provided)
Easy Apply
A valid California driver’s license, a current DMV printout, and access to a personal vehicle for site travel. Set up samples for testing.…
21d
Lifecore Biomedical
3.2
Sterility Assurance Engineering Manager
Chaska, MN
$130K - $160K (Employer provided)
Advanced critical thinking, root cause analysis, and technical investigation skills. Demonstrated expertise in risk assessment tools (e.g., FMEA, FTA) and……
30d+
Denali Ingredients
3.3
Quality Systems & Assurance Director
New Berlin, WI
$106K - $153K (Glassdoor est.)
Easy Apply
Bachelor’s degree in food science, Dairy Technology, Microbiology, or a related field. Proficiency in quality control tools, data analysis, and problem-solving……
17d
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……
24h
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
DSDT
MRI Associate Degree Program Director
Detroit, MI
$70K - $85K (Employer provided)
Easy Apply
A minimum of a bachelor degree in Radiologic Sciences or a related field. Conduct regular advisory board meetings with field professionals to ensure ongoing……
30d+
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. HACCP and/or SQF Practitioner certification is a plus.…
10d

Ultragenyx

3.4

Executive Director, CMC QA

Novato, CA

$294K - $363K (Employer provided)

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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

21,001 Associate Director, Quality Management jobs in United States

Position Summary:

Work Model:

Responsibilities:

Requirements:

Physical Demand Requirements:

Base pay range

Working here doesn’t have to be a secret

Position Summary:

Work Model:

Responsibilities:

Requirements:

Physical Demand Requirements:

Base pay range

Working here doesn’t have to be a secret