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.…
16d
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.…
16d
Crane Aerospace & Electronics
2.7
Aerospace Program Manager
Elyria, OH
$84K - $122K (Glassdoor est.)
Some e xperience in a technical field preferred , preferably aerospace. Identify, manage, and assist in mitigation of program risks (technical, schedule, and……
30d+
PharMerica
2.6
Pharmacist
Asheville, NC
$119K - $138K (Glassdoor est.)
License/Certification(s): current and valid pharmacist license in the state of practice. Ensure compliance with all state and federal regulatory requirements……
25d
Martin Marietta Materials
3.7
Project Maintenance Engineer, PE
Manistee, MI
$83K - $107K (Glassdoor est.)
Guide the design implementation process including conceptual, schematic, design development and construction documentation of large capital projects; including……
30d+
Terracon
3.8
Geotechnical Department Manager I
Tulsa, OK
Valid driver’s license with acceptable violation history. Certification or licensure in field of expertise. Bachelor’s degree in technical discipline practiced……
30d+
IDEA Public Schools
2.8
Special Education RISE Teacher - IDEA Lopez Academy (26-27)
Odessa, TX
$64K (Employer provided)
Licenses or Certifications: Valid Texas state certification in Special Education (required); appropriate grade and subject band core content certification(s) or……
30d+
Poclain Hydraulics
3.4
Maintenance & Reliability Manager
Sturtevant, WI
$125K - $150K (Employer provided)
Easy Apply
This individual must possess deep technical expertise in industrial manufacturing systems, including CNC machining centers, PLC-controlled automation, robotics,……
30d+
Lunda Construction
3.7
Safety Manager
Milwaukee, WI
$74K - $105K (Glassdoor est.)
This position reports to the Safety Director and partners closely with project managers, superintendents, field personnel, and corporate leadership to minimize……
4d
IvoryCloud
4.9
Operations Manager (US Citizenship/FT in-office Required)
Carlsbad, NM
$95K - $110K (Employer provided)
Easy Apply
Ability to *develop and implement training programs and operational guides* measurable by successful onboarding of new operators and positive feedback from……
17d
TRICOR Insurance
4.0
Personal Risk Manager
Viroqua, WI
$103K - $164K (Glassdoor est.)
Leverage technology and tools to enhance service delivery and efficiency. Provide a best-in-class client experience through proactive outreach and ongoing……
30d+
Torch Technologies
3.6
Cybersecurity ISSE (Principal)
Kettering, OH
$100K - $146K (Glassdoor est.)
Bachelor’s degree in a related field and 10 years of experience in the respective technical/professional discipline being performed.…
30d+
Tier 1 Fire Protection
Low Voltage Estimator
Brownsville, TN
$25.00 - $35.00 Per Hour (Employer provided)
3+ years of experience in low voltage estimating, project management, design, installation, or related field. This role analyzes project plans, specifications,……
26d
Aegis Security Insurance Company
Associate Attorney
Phoenix, AZ
$125K - $175K (Employer provided)
Easy Apply
Participate in the evaluation, implementation, and governance of technology solutions and AI-driven tools designed to improve claims handling, litigation……
30d+
Wallace Electric
4.5
Commercial and Industrial Electrical Project Executive
Atlanta, GA
$150K - $175K (Employer provided)
Easy Apply
*Master Electrician License* or equivalent state electrical license. *DBIA Design-Build Professional™* certification (preferred for design-build project……
4d
Farnsworth Group Inc
3.5
Mechanical Engineering Manager - Healthcare
Peoria, IL
$120K - $171K (Employer provided)
Easy Apply
Mentor, coach, and develop mechanical engineers and designers, providing technical guidance, performance feedback, and support for career growth.…
30d+
Enterprise Builders
Senior Project Manager
Albuquerque, NM
$85K - $100K (Employer provided)
Easy Apply
Experience with design-build and construction manager at risk contracts preferred. Bachelor’s Degree in Construction Management, Engineering, Architecture, or……
30d+
Crane Nuclear
3.1
Nuclear Technical Manager
Twinsburg, OH
$100K - $134K (Glassdoor est.)
Easy Apply
Lead collaboration efforts with other divisions of Crane Nuclear and Process & Flow Technologies, technical title holders, and other technical managers with the……
24h
Infiltrator Water Technologies
3.8
Project Manager II
Sutherlin, OR
$74K - $99K (Glassdoor est.)
Must be able to meet and maintain Orenco's approved driver criteria; a valid driver's license, satisfactory driving record, current insurance on personal……
30d+
Finger Lakes Addictions Counseling & Referral Agency
1.9
CHHUNY High Needs Care Manager
Geneva, NY
$20.00 - $22.00 Per Hour (Employer provided)
Easy Apply
New York State driver’s license, safe driving record. Comprehensive client centered care planning development and management with the child/youth and parent/……
30d+
Memorial Healthcare (Michigan)
3.7
Registered Nurse - Recent Wage Adjustment Completed! - $15k Sign on Offered to External Candidates!
Owosso, MI
Assures quality of care by adhering to therapeutic standards; measuring health outcomes against patient care goals and standards; making or recommending……
30d+
Freudenberg Group
3.5
Technical Project Engineer - -Static Sealing Solutions North America
Broken Arrow, OK
This role requires advanced technical knowledge of expansion joints, material knowledge, process and engineering tools knowledge and the ability to manage and……
13d
Integrated Biometrics
Product Solutions Manager
Chandler, AZ
$105K - $160K (Employer provided)
Easy Apply
*Pre-Sales Technical Leadership:* Lead technical discovery sessions, design custom biometric software solutions, and serve as a trusted technical advisor……
23d
NIFCO America Corp
3.2
IT Application Manager
Canal Winchester, OH
$72K - $117K (Glassdoor est.)
Easy Apply
Bachelor’s degree in Information Technology, Computer Science, or related field preferred. My role requires that I build strong customer relationships and……
30d+
Lawrence Lee Construction Services, Inc.
Estimator – Wastewater Management
Stuart, FL
$90K - $120K (Employer provided)
Easy Apply
Associate's or Bachelor's degree in Construction Management, Civil Engineering, Mechanical Engineering, or a related field preferred. 401(k) with company match.…
4d
St. John's United
3.4
Director of Accounting and Controller
Billings, MT
$85K - $127K (Glassdoor est.)
Easy Apply
Assist with the design and implementation of accounting practices and internal controls that satisfy audit requirements. Provide immediate service-listen & act.…
3d
Teck Resources Limited
4.0
Senior Engineer, Tailings and Closure
Idaho
$101K - $131K (Employer provided)
Provide rigorous contractor and consultant management, including scope development, budgeting, execution oversight, safety compliance, quality control, and……
19d
Moses Lake Industries
3.6
COMMODITY SPECIALIST
Moses Lake, WA
$65K - $88K (Employer provided)
A relevant degree, equivalent work experience, professional certification, college degree with a minimum of 2 years supply chain work experience or path to……
30d+
Curry Health Network
2.7
Controller
Medford, OR
$76.60 - $96.92 Per Hour (Employer provided)
Easy Apply
None of the time: Extreme heat/cold; Wet/humid; fumes/airborne particles; work with explosives; vibration; outdoor weather; Working near moving mechanical parts……
30d+
Bunnell-Lammons Engineering
3.3
Senior Geologist | Regional Geotechnical
Columbia, SC
$89K - $122K (Glassdoor est.)
Easy Apply
Apply advanced technical knowledge to develop and implement investigative strategies and remedial approaches. Guide the selection and application of appropriate……
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

107,303 Manager technology risk 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