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.…
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
Whatcom Community College
4.2
Project Manager Cybersecurity Grants
Bellingham, WA
$63K (Employer provided)
Easy Apply
Bachelor's degree in project management, business administration, information technology, cybersecurity, computer science, management information systems or a……
24h
MTSI
4.8
SIM Operations Engineer
Edwards AFB, CA
8+ years’ experience in related engineering discipline. 5+ years’ experience in flight test (operations engineer, test conductor/director, or discipline……
30d+
Northwest Iowa Community College
Director of Medical Laboratory Sciences Programs
Sheldon, IA
$27.00 Per Hour (Employer provided)
Easy Apply
Coordinate with the Healthcare Clinical Coordinator to interview, hire, and evaluate MLS clinical instructors; arrange contracts for use of clinical facilities;……
30d+
The New Flat Rate
National Training Director
Dalton, GA
$56K - $97K (Glassdoor est.)
Easy Apply
This means leading our flagship two-day and three-day training events, coaching sessions, Q&A calls, ride alongs, and more — while also building the curriculum……
28d
LINX
3.6
Low Voltage Project Manager - Commercial Construction - SLC
Salt Lake City, UT
$85K - $100K (Employer provided)
Easy Apply
Demonstrated experience interacting regularly with client-side stakeholders including IT directors, facilities managers, and general contractors and electrical……
8d
Mosaic Life Care
3.5
Athletic Trainer - Middle / High School
Saint Joseph, MO
$63K - $99K (Glassdoor est.)
Participates in professional development activities and maintains licensure and other professional affiliations, including BOC certification and state……
30d+
Hubble Studio
AI Systems Specialist & Front Office Manager at Production Studio
Los Angeles, CA
$20.00 - $28.00 Per Hour (Employer provided)
Easy Apply
Experience with social media platforms and automation tools (scheduling, analytics, content pipelines). Clear communicator — you'll be the bridge between the……
24h
Mosaic Life Care
3.5
Athletic Trainer - Savannah High School
Saint Joseph, MO
$65K - $116K (Glassdoor est.)
Participates in professional development activities and maintains licensure and other professional affiliations, including BOC certification and state……
30d+
AuST Manufacturing
3.9
Director of Technical Operations
West Valley City, UT
$96K - $147K (Glassdoor est.)
Easy Apply
You have personally designed and built automated manufacturing equipment — not supervised a vendor who built it, but done the mechanical design, electrical……
30d+
LINX
3.6
Structured Cabling Project Manager - Commercial Construction
Salt Lake City, UT
$85K - $100K (Employer provided)
Easy Apply
Demonstrated experience interacting regularly with client-side stakeholders including IT directors, facilities managers, and general contractors and electrical……
8d
Deltavision Media LLC
Meteorologist/Reporter
Pocatello, ID
$33K (Employer provided)
Easy Apply
Direct field operations as requested. Use of enterprise skills to identify news stories for delivery on television and the ability to consistently translate……
30d+
Wholesale Payments
2.7
Sales Director – Build & Lead a National Sales Team
Lubbock, TX
$150K - $250K (Employer provided)
Easy Apply
This is a 1099 independent contractor leadership role designed for someone with an entrepreneurial mindset who wants to build long-term residual income through……
30d+
Columbus Hydraulics-- A Wipro Hydraulics Company
CWI/ Welding Engineer
Columbus, NE
Easy Apply
5+ years of experience in an occupational function that has a direct relationship to the design, production, construction, or repair of weldments being……
24d
Albany Damien Center
4.0
Data & IT Manager
Albany, NY
$70K - $75K (Employer provided)
Easy Apply
Bachelor’s degree in data or computer science or related field with a strong emphasis on data collection, validation, management, and utilization.…
24d
Wake Forest University
4.1
Assistant Manager Irrigation Systems, Facilities and Campus Services
Winston-Salem, NC
$42K - $62K (Glassdoor est.)
Knowledge of underground lawn irrigation repair and installation techniques and the design and redesign of irrigation systems.…
30d+
Patrick Industries
3.5
IT Director of Architecture (Elkhart, Indiana, US, 46516)
Elkhart, IN
$65K - $105K (Glassdoor est.)
Define and own the CMDB strategy, taxonomy, and governance model, ensuring it is accurate, trusted, and actively used. End‑user and operational technologies.…
30d+
Altoona Nursing & Rehabilitation Center
2.5
Director of AI & Automation
Des Moines, IA
$190K (Employer provided)
Easy Apply
Bachelor's degree in Business, Technology, Information Systems, Engineering, Computer Science, or related field. Technology strategy: 5 years (Required).…
24h
Nodak Insurance
2.0
Senior Commercial Underwriter
Fargo, ND
$63K - $93K (Glassdoor est.)
Under direction and within authority, reviews and underwrites applications, renewals, endorsement requests, reinstatements and rewrites on an account basis and……
30d+
Seven Peaks School
Director of Development
Bend, OR
$70K - $85K (Employer provided)
Easy Apply
Preference given to candidates who have held the title of Director of Development or the equivalent in a non-profit/independent school.…
30d+
Global Water
3.3
Senior Civil Engineer
Maricopa, AZ
$96K - $144K (Glassdoor est.)
Easy Apply
Licenses: Must have a valid Arizona driver’s license. Ability to interpret, understand, and apply engineering standards and procedures, applicable federal and……
30d+
Sierra County (California)
2.7
Sierra County Director of Behavioral Health
Loyalton, CA
$14,027 (Employer provided)
Easy Apply
The Director supervises the work of clinical and administrative staff assigned to the respective programs and activities to ensure compliance with all……
17d
Coleman Environmental Engineering Inc.
Product Manager
Spokane, WA
$180K (Employer provided)
Easy Apply
Valid U.S. driver's license. Identify technical risks early and drive solutions across engineering, design, and operations.…
24d
Public School Retirement Systems of Missouri
Director of Internal Audit
Jefferson City, MO
$146K - $182K (Employer provided)
Easy Apply
Valid Missouri driver’s license. Bachelor’s degree in accounting, business, or a related field (master’s preferred).…
10d
Monroe College
3.5
Athletic Trainer - Monroe University
New Rochelle, NY
$67K - $68K (Employer provided)
Easy Apply
They are responsible for the prevention, evaluation, management, and rehabilitation of injuries within the university’s comprehensive sports medicine program……
17d
MassMutual
3.5
Actuarial Director of Life Products Financial Reporting
Boston, MA
$160K - $210K (Employer provided)
Bachelor’s degree in actuarial science, mathematics, statistics, finance, data science or closely related field. Focused one-on-one meetings with your manager.…
30d+
Grace Place for Children and Families
3.6
Director, Development Strategy and Communications
Naples, FL
$74K - $117K (Glassdoor est.)
Easy Apply
A valid driver’s license, acceptable driving record, and active automobile insurance are required when driving is necessary.…
21d
Mountain Pathways School
Operations Director
Boone, NC
$48K (Employer provided)
Easy Apply
Have two years full-time work experience in a child care center or early childhood work experience; or undergraduate, graduate, or associate degree with 12……
4d

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

157,066 IS/IT Director 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