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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.…
13d
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.…
13d
Ultragenyx
3.4
Sr. Facilities Engineer
Bedford, MA
$158K - $195K (Employer provided)
Exercises independent judgment to determine and recommend appropriate actions on behalf of engineering and represents engineering programs to external……
22d
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+
PMX Industries
3.5
Engineering Manager
Cedar Rapids, IA
Easy Apply
Previous machine design and project management experience required. Maintain and communicate status of proposed and approved capital projects and engineering……
30d+
Confidential
Senior Transformation Engineer (Multi-Site)
East Aurora, NY
$125K - $150K (Employer provided)
Easy Apply
Provide engineering support across multiple manufacturing locations. 3–7+ years of experience in machining/manufacturing environments.…
22d
DW Products
Quality Manager CNC Inspection & Customer Quality
Cedar Rapids, IA
Easy Apply
DW Products is hiring a hands-on Quality Manager to own part quality, inspection discipline, CMM measurement, and customer quality performance across our……
21d
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+
Amazon
3.5
Sr. Manager, Design Program Management, Devices and Services Design Team
Seattle, WA
$160K - $217K (Employer provided)
You will be responsible for building and developing a high-performing team, driving cross-organizational program excellence, and serving as a key member of the……
24h
Ramsey Companies, Inc.
Director of Operations
Wapato, WA
$150K (Employer provided)
Easy Apply
10+ years of progressive leadership experience in fuel/petroleum distribution, wholesale marketing, or high-volume logistics, preferably with multi-state or……
30d+
Tata Chemicals
3.9
Quality Assurance Foreperson
Green River, WY
$120K - $135K (Employer provided)
Easy Apply
Bachelor’s degree in Chemistry or related field with 5-7 years of directly related experience or an equivalent combination of education and experience.…
3d
Confidential
Production Manager & RF Engineer
Simi Valley, CA
$90K - $120K (Employer provided)
Easy Apply
Bachelor’s degree in electrical engineering or equivalent work experience. 3+ years of RF laboratory, engineering, or electronic manufacturing experience.…
30d+
Parnell
Plant Director
Menomonie, WI
$140K - $165K (Employer provided)
Easy Apply
Bachelor’s degree in engineering, Operations, Supply Chain, Pharmaceutical Sciences, or a related field required; Reliable production output and service levels.…
13d
Titomic
4.3
Director of Advanced Manufacturing Engineering, Materials & Processes
Madison, AL
$130K (Employer provided)
Easy Apply
Lead the development, optimization, and qualification of cold spray processes—including parameter development, powder feedstock selection, nozzle design,……
30d+
Sealed Air Corporation
3.3
NAM Technical Manager
Grand Prairie, TX
$94K - $148K (Glassdoor est.)
5+ years of technical, maintenance, or reliability engineering in a regional/multi-site manufacturing environment. Bachelor’s degree in Engineering required.…
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+
The Hershey Company
3.5
Lead Controls Systems Specialist - OSI PI
Lancaster, PA
$64K - $90K (Glassdoor est.)
Working knowledge of control system components and architecture which includes PLCs, Kepware OPC, Networking (TCP/IP), HMI/SCADA systems as well as other state……
30d+
Stellant
2.9
Director of Operations
Williamsport, PA
$100K - $153K (Glassdoor est.)
They will be a passionate, lean transformation champion with demonstrated success driving a “from scratch” transformation (both process and culture) and the……
30d+
Wedgewood Pharmacy
2.5
Quality Manager - 503b cGMP Environment
Athens, OH
$110K (Employer provided)
Easy Apply
Assist in leading all regulatory inspections of the site, including inspections from FDA and state Boards of Pharmacy. How You Will Make an Impact.…
30d+
Confidential
Vice President of Engineering
Universal City, TX
$130K - $175K (Employer provided)
Easy Apply
Lead and mentor multidisciplinary engineering teams specializing in avionics systems, software development, system design, and integration.…
30d+
Voltage
Quality Assurance Engineer
Timberlake, NC
$57K - $81K (Glassdoor est.)
Easy Apply
The Quality Assurance Engineer is responsible for supporting the development, implementation, and continuous improvement of quality systems, manufacturing……
30d+
H. H. Dobbins
3.2
Maintenance and Sanitation Manager
Lyndonville, NY
$125K (Employer provided)
Easy Apply
Bachelor’s degree in mechanical, electrical, or industrial engineering, or related technical field preferred; equivalent technical training and experience will……
2d
DEDIENNE AEROSPACE, LLC
Senior Procurement Mechanical Engineer
Miami, FL
$85K (Employer provided)
Easy Apply
Evaluate and select vendors based on their technical capabilities, having a strong understanding of part manufacturing and the ability to translate design……
30d+
Fabworx Solutions, Inc.
Semiconductor Field Service Manager (10 Year Minimum)
Austin, TX
Easy Apply
In addition to managing and performing installations, you will serve as the primary point of escalation for complex technical issues from the field, working……
12d
Laborup
1.0
Quality Manager - Aerospace Machining
San Jose, CA
$108K - $150K (Employer provided)
Easy Apply
You'll own quality systems, certifications, audits, inspection processes, and continuous improvement to ensure every part meets the highest customer standards.…
10d
Valence Surface Technologies
2.8
Lead Quality Process Engineer – Aerospace Shot Peening & Chemical Processing
Paramount, CA
$90K - $120K (Employer provided)
Easy Apply
Related technical field, or equivalent aerospace industry experience. Develop and maintain operator training, qualification, and certification programs.…
30d+
Royal Apparel
2.7
Cutting Room Manager- Knit Apparel
Hauppauge, NY
$80K - $100K (Employer provided)
Easy Apply
Train, coach, and hold cutting room operators and leads accountable. Lean manufacturing or continuous improvement background.…
16d
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+
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+

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

1,040,067 Director, Quality Systems 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