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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.…
18d
Ultragenyx
3.4
Executive Director, CMC QA
South San Francisco, CA
$294K - $363K (Employer provided)
Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.…
18d
StandardAero
3.2
Trade Compliance Manager
San Antonio, TX
$79K - $118K (Glassdoor est.)
Manage classification, valuation, country of origin determinations, licensing, and recordkeeping for aerospace parts, engines, tooling, and technical data.…
30d+
MCT Companies
3.7
Working Service Manager for Small Shop in Schuyler, NE
Schuyler, NE
$26.00 - $42.00 Per Hour (Employer provided)
Easy Apply
Working under the supervision and guidance of the service manager and director of service, performs a variety of specific technical, and assistive functions;……
30d+
Foundation for California Community Colleges
3.3
Inspection Assistant, BAR (Chaffey College)
Haven, CA
$18.00 - $22.00 Per Hour (Employer provided)
Knowledge of current principles and practices of automobile repair and technology, including California state and local automotive repair policies and codes,……
30d+
Particle Measuring Systems
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Lead Opto‑Electronics Engineer
Niwot, CO
$140K - $175K (Employer provided)
Design and develop ultra‑low‑noise, high signal‑to‑noise analog front‑end electronics for optical detection systems. PhD in a relevant technical discipline.…
30d+
FMI
3.3
Cost Estimator - Senior
Biddeford, ME
$60K - $85K (Glassdoor est.)
The Senior Cost Estimator will also take a lead role in planning strategic direction for the group by seeking out new tools within or in addition to the……
30d+
Frontline Wildfire Defense
5.0
Senior Construction Project Manager - Jackson, WY
Jackson, WY
$120K - $134K (Employer provided)
Easy Apply
Must have a valid driver’s license and reliable vehicle for travel to job sites. Partner with engineering and design teams to refine system layouts,……
4d
SRM Concrete
2.6
Divisional Quality Control Manager
Dallas, TX
$84K - $140K (Glassdoor est.)
ACI certification preferred and/or the ability to obtain ACI certifications. Collaborate with production, operations, sales, and technical services teams to……
30d+
BASF
3.8
Account Manager - Beauty Care Solutions
Florham Park, NJ
$128K - $160K (Employer provided)
Hold a bachelor's degree in biology, biochemistry, or related field; Advanced degree is preferred. Identifying, qualifying, and driving new business……
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……
14d
CPZ Architects, Inc.
Architectural Senior Project Manager
Fort Lauderdale, FL
$120K - $140K (Employer provided)
Easy Apply
Comprehensive understanding of structural, civil, mechanical, electrical, and plumbing building systems. Strong organizational skills, technical expertise, and……
30d+
Endpoint Industrial Controls
Electrical Engineering Project Estimator
Loveland, CO
$65K - $80K (Employer provided)
Easy Apply
Ability to interpret electrical schematics, one-line diagrams, panel layouts, engineering drawings, and technical specifications.…
3d
Hotstart Inc
Business Development Manager - Industrial & Heavy Duty Markets
Spokane Valley, Spokane, WA
$79K - $95K (Employer provided)
Easy Apply
Stay informed on customer announcements, technical developments, and industry trends. The company provides a strong benefit package highlighted by premium-free……
12d
Enbridge
3.8
Engineer Specialist, System Planning
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$98K - $129K (Glassdoor est.)
Provide technical leadership, mentorship, and coaching while driving cross-functional collaboration and continuous improvement initiatives.…
10d
Enbridge
3.8
Operations Coordinator
Hereford, TX
$53K - $75K (Glassdoor est.)
Valid driver's license and ability to obtain a passport. Electrical education, certification, or experience working with high-voltage electrical systems.…
6d
HOERBIGER
3.7
Engineering - CAD-PLM Administrator
Waukegan, IL
$66K - $99K (Employer provided)
Identify, develop, implement, and provide training and mentoring for new processes and best practices in PDM/CAD/ERP software for all users.…
30d+
Cornerstone Controls
4.5
Solutions Architect/Inside Sales Engineer
Indianapolis, IN
$50K - $70K (Employer provided)
Easy Apply
Experience with the project execution lifecycle and technical field services. The solutions architect group produces proposals for automation controls equipment……
30d+
Avangrid
3.5
Lead Engineer - Protection & Control
Augusta, ME
$111K - $146K (Employer provided)
Practical engineering experience/application - Planning, Operations and Engineering Design, Construction, (e.g., field experience, standardization "Perform……
30d+
Torch Technologies
3.6
Cybersecurity, Senior (ISSM)
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$87K - $145K (Glassdoor est.)
Master's or Doctorate Degree in a related field and 10 years of experience in the respective technical/professional discipline being performed, five years of……
30d+
DBSI
3.5
Architectural Project Manager
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$86K - $123K (Glassdoor est.)
Easy Apply
Coordinate architectural, interior design, engineering, and construction teams to ensure project alignment and delivery. 401(k) with company match.…
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Altria
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IT Site Support Manager
Hopkinsville, KY
$120K - $173K (Employer provided)
Shown success leading incident management, root cause analysis, and resolution of complex technical issues. Help with your goals — get help with student loan……
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The Hershey Company
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Reliability Lead
Bluffton, IN
$66K - $97K (Glassdoor est.)
Associate’s degree in a related technical field. Must wear PPE required for manufacturing or construction sites, including hearing and eye protection, hard hat,……
30d+
Resource Environmental Solutions
3.3
Technical Engineering Lead
Annandale, VA
$131K - $152K (Employer provided)
This is an opportunity for a seasoned engineering leader to step away from day-to-day design production and focus on managing a book of business, shaping……
18d
Resource Environmental Solutions
3.3
Technical Engineering Lead
Richmond, VA
$131K - $152K (Employer provided)
This is an opportunity for a seasoned engineering leader to step away from day-to-day design production and focus on managing a book of business, shaping……
19d
Hotstart Inc
Business Development Manager - Industrial & Heavy Duty Markets
Sheboygan, WI
$79K - $95K (Employer provided)
Easy Apply
Stay informed on customer announcements, technical developments, and industry trends. The company provides a strong benefit package highlighted by premium-free……
12d
Lamar Advertising
4.4
Logos Market Manager
Helena, MT
$50K (Employer provided)
Easy Apply
Strategic, operations and technical Marketing and Management skills. Skill in speaking with persons of various social, cultural, economic, and educational……
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Wake Technical Community College
3.8
Director, Fire & Rescue Services
Raleigh, NC
$75K - $112K (Employer provided)
Ensures compliance with all applicable state and federal laws, certification standards, and safety regulations. Master’s degree in a related field.…
30d+
ADG Architecture, llc
PROJECT MANAGER
United States
$65K - $80K (Employer provided)
Easy Apply
The Project Manager will oversee multiple projects from programming through construction administration while collaborating closely with clients, consultants,……
28d
Bliss Roofing
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Bend, OR
$70K - $100K (Employer provided)
Easy Apply
Valid driver's license with a clean driving record. Serve as a technical resource for crew leaders, answering roofing or ServiceTitan-related questions.…
20d

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

118,615 Technical impact 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