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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.…
15d
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.…
15d
Paradigm Healthcare
3.9
Director of Nursing
Silsbee, TX
$80K (Employer provided)
Easy Apply
Must possess a current, unencumbered, active license to practice as a Registered Nurse in the State. Ensure that staffing procedures include a sufficient number……
30d+
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+
Graham Regional Medical Center
4.1
Director of Surgical Services
Graham, TX
$160K (Employer provided)
Easy Apply
Valid RN license in Texas required. Maintain professional growth and development through seminars, workshops, and professional affiliations to keep abreast of……
30d+
Whiteville Area Post-Acute Care Practice
Post-Acute Medical Director in Whiteville, NC
Whiteville, NC
$130K - $146K (Employer provided)
Our comprehensive clinical and operational leadership team will support your transition into our medical practice with a comprehensive 3-month onboarding……
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.…
15d
Nye Technology Solutions
Director of Nursing (DON) - RN
Lincoln, NE
$95K - $115K (Employer provided)
Easy Apply
Active, unencumbered Registered Nurse (RN) license in the state of Nebraska. Survey Outcomes: Annual state and federal surveys with fewer than 5 tags.…
30d+
Westwood Manor Nursing Home, LLC
Director of Nursing
Deridder, LA
$75K - $125K (Employer provided)
Easy Apply
The DON will collaborate with other healthcare professionals to develop care plans and improve patient outcomes while fostering a supportive environment for……
11d
Sheridan College (Wyoming)
3.4
Director of Residence Life and Housing
Gillette, WY
$55K - $67K (Employer provided)
Possess a valid driver's license. Master's degree in Higher Education Administration or a closely related field. Previous live-in residence experience.…
30d+
The Y (YMCA)
3.8
Aquatics Director
Alexandria, MN
$44K - $66K (Employer provided)
Easy Apply
Associate's degree in Health Science, Recreation, or related field. 1+ years of experience in an Aquatics-related field. 401(a) and 403(b) Retirement Plans.…
30d+
Trivium Packaging
3.4
Supply Chain Director
Youngstown, OH
$103K - $166K (Glassdoor est.)
Utilize analytical tools and techniques to extract actionable insights from data, driving continuous improvement in forecasting accuracy, demand planning,……
30d+
Mercyhealth
3.0
Assistant Director of Nursing, Long-Term Care
Harvard, IL
$37.29 - $59.67 Per Hour (Employer provided)
Easy Apply
Current, active RN license in Illinois or Wisconsin required. Ability to read, interpret, and apply federal and state regulations, policies, and clinical……
9d
SRM Concrete
2.6
Divisional Training Director
Detroit, MI
$63K - $108K (Glassdoor est.)
Oversee Regional Training Managers: Provide leadership, mentorship, and support to Regional Training Managers and plant-level trainers, empowering them to……
30d+
Universal Remote Control
3.0
Vice President/Senior Director, Marketing
Harrison, NY
$140K - $160K (Employer provided)
Easy Apply
Bachelor’s degree in marketing or related field. Oversee company websites, dealer portals, social platforms, and digital content strategies.…
14d
Preferred Electrical
3.0
Director of Estimating
Bloomingdale, IL
$140K - $210K (Employer provided)
Easy Apply
Strong understanding of NEC, construction methodologies, and cost analysis principles. This executive-level role will oversee the Chief Estimator and team,……
30d+
Titomic
4.3
Director of Material Science – Titomic Cold Spray
Madison, AL
$130K (Employer provided)
Easy Apply
Bachelor's degree in Materials Science/Engineering or another engineering field with a strong materials science/metallurgy emphasis (Master’s or PhD preferred).…
30d+
Forum Plastics
4.6
Manager of Regulatory Affairs & Customer Quality
Watertown, CT
$75K - $90K (Employer provided)
Easy Apply
Coordinate root cause analysis and implement CAPAs within the enterprise using cross functional teamwork to maintain high customer satisfaction ratings and……
24h
Engineers & Surveyors Institute
Executive Director - Civil Engineering Membership Organization
Chantilly, VA
Easy Apply
Qualified candidates should be a licensed Professional Engineer, Surveyor or related discipline and have a minimum of 10 years demonstrated leadership and……
29d
Kentucky State University
2.9
Asst Professor Applied Percussion/Associate Director of Bands
Frankfort, KY
Easy Apply
Engage in scholarly research and creative activities, contributing to the field of music. Doctoral Degree in Music is Preferred with a specialization in……
30d+
Box Butte Development Corporation
Executive Director
Alliance, NE
$65K - $72K (Employer provided)
Easy Apply
Maintain certifications including Alliance’s Economic Development Certified Community certification and Hemingford’s Leadership Certified Community……
4d
Klus Inspiring Solutions
2.9
Manager of Engineering and Product Support
Vero Beach, FL
$10.00 Per Hour (Employer provided)
Easy Apply
We are seeking a hands-on Manager of Engineering and Product Support to lead our Engineering team and oversee all engineering support functions, including……
3d
CFG Health
1.0
Director of Nursing (DON)
Tallahassee, FL
$100K - $110K (Employer provided)
Easy Apply
Current, unrestricted Registered Nurse (RN) license in the state of practice. Bachelor of Science in Nursing (BSN) required, master’s in nursing, Healthcare……
24h
Precision Armament
Director of Compliance
Wellsville, NY
$65K - $90K (Employer provided)
Easy Apply
Valid driver’s license and ability to travel between Company facilities as needed. Overseeing firearm-related compliance, including ATF records, A&D records,……
9d
KTL Solutions
3.6
CMMC CCA Consultant
Frederick, MD
$50.00 - $65.00 Per Hour (Employer provided)
Easy Apply
Support business development efforts by participating in client discovery calls, proposal development, and capability briefings.…
30d+
CSL Plasma
3.1
Director, Regional Ecosystem Lead (San Diego)
San Diego, CA
$232K - $284K (Employer provided)
Serve as a senior member of deal teams occurring in each region, supporting transactions from identification through due diligence and help lead relationships……
30d+
Lussier Community Education Center
Director of Development
Madison, WI
$74K (Employer provided)
Easy Apply
Identify and pursue funding opportunities through grants, foundations, local, state, and federal government, and other revenue generating resources.…
11d
Confidential
Regional Director of Workforce Partnerships
Richmond, VA
$90K - $185K (Employer provided)
Easy Apply
*Funding Navigation:* Assist partners in identifying WIOA grants and state workforce funding to support student tuition and program costs.…
24h
Infusion For Health
3.3
Clinical Operations Manager (Nurse Practitioner)
Corona, CA
$150K - $160K (Employer provided)
Easy Apply
\*\**Must have an active Nurse Practitioner (NP) license in the state of California.*\*\*. Collaborate with healthcare professionals to develop and implement……
30d+
Nativity of the Lord Parish
Associate Director of Youth Ministry and Adult Formation
DeForest
$45K - $48K (Employer provided)
Easy Apply
This includes, but is not limited to talks, retreats, religious education, social events, recreation, community service outreach and liturgical celebrations.…
11d

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

134,500 Director-level Role 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