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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.…
17d
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.…
17d
Ultragenyx
3.4
Associate Director, Global Medical Communications
Novato, CA
$191K - $236K (Employer provided)
Collaborate with Medical Information and other Medical Affairs colleagues to ensure scientific accuracy and message consistency across standard responses,……
30d+
Amberwell Health
3.3
Director of Emergency Care
Hiawatha, KS
$57K - $97K (Glassdoor est.)
Ensures compliance with certification and accreditation standards in accordance with Amberwell policies and procedures. Attends other meetings as necessary.…
30d+
Swope Health Services
3.2
Clinic Manager RN - St. Joseph KidsCare Pediatric
Saint Joseph, MO
$85K (Employer provided)
Easy Apply
Licensed in Missouri; Dual license preferred in MO & KS. Bachelors or better in Nursing or related field. Leads and role models patient experience efforts and……
30d+
Swope Health Services
3.2
Clinic Manager RN - Leavenworth Clinic
Leavenworth, KS
$80K (Employer provided)
Easy Apply
Completes Environmental Protection Agency (EPA) certification on bio hazardous waste and Department of Transportation (DOT) certification on transporting……
30d+
Immanuel Living
3.8
LPN / RN Resource Nurse
Kalispell, MT
$29.00 - $40.00 Per Hour (Employer provided)
Easy Apply
Assist in dining rooms with meals, passing trays/feeding residents/guests. Implement resident/guest plan of care or assist other licensed personnel in……
30d+
State of Colorado
3.6
CDOC Correctional Officer I - Buena Vista
Riverside, Chaffee, CO
$4,839 - $6,775 (Employer provided)
Possess a valid and unrestricted driver’s license; Drivers must maintain a valid, non-restricted Colorado driver's license, obey traffic laws, and be able to……
30d
ProviderTrust
4.3
Primary Source Partnerships Manager
Nashville, TN
$58K - $89K (Glassdoor est.)
Research, outreach drafting, agreement tracking, and pipeline monitoring are supported by AI tools, freeing this individual to concentrate on what AI cannot do:……
6d
Watertown, South Dakota
Parks and Forestry Superintendent | City of Watertown
Watertown, SD
$78K - $88K (Employer provided)
Easy Apply
Prepares requests for purchase of services, materials and supplies and solicit quotes from suppliers, contractors, architects and surveyors within the City’s……
10d
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+
Community Living Services
3.3
Self Determination Coordinator (Macomb)
Macomb, IL
$38K - $51K (Glassdoor est.)
Maintenance of a valid driver’s license, an acceptable driving record, and vehicle registration and insurance in compliance with State of Michigan requirements……
30d+
Phoebe Putney
3.4
Director, Imaging
Albany, GA
Master's Degree or other Degree in MBA, MHA, or related field (Preferred). Demonstrates technical skill in using equipment appropriate for role.…
30d+
Family Services
3.0
Clinician/Therapist (LMSW, LCSW, LMHC, LMFT)
United States
$55K - $75K (Employer provided)
Complete a differential diagnosis for clients and refer them to the appropriate program(s) and/or case manager/licensed prescriber for services not under this……
30d+
SIU Medicine
3.0
Sr Construction Project Manager (5012)
Springfield, IL
$7,089 - $7,798 (Employer provided)
The Senior Construction Project Manager is responsible for the scope, budget, and schedule management, contract administration, design and construction,……
30d+
ComServ
3.9
Residential Manager Little River Group Home
Taylorsville, NC
$39K - $56K (Glassdoor est.)
A valid NC drivers license and a safe driving record acceptable under ComServ, Inc. liability carrier is required. Delegates coverage as needed and as approved.…
30d+
Greer's
2.9
Store Director
McIntosh, AL
$50K - $80K (Glassdoor est.)
Easy Apply
Bachelor’s degree in Business Administration or related field, or an equivalent combination of education and/or experience.…
30d+
Family Services
3.0
Clinician/Therapist (LMSW, LCSW, LMHC, LMFT)
Poughkeepsie, NY
$55K - $75K (Employer provided)
Complete a differential diagnosis for clients and refer them to the appropriate program(s) and/or case manager/licensed prescriber for services not under this……
30d+
Oregon Health & Science University
3.6
Director Of Nursing, Pediatric Perioperative Services
Portland, OR
$200K - $267K (Employer provided)
Current unencumbered Oregon RN license. BSN required AND • Master’s degree in nursing or related field required. Required within 3 years of hire.…
11d
Thermogenics
3.9
General Manager
Cincinnati, OH
$100K - $140K (Employer provided)
Easy Apply
Drive initiatives and a culture that delivers field service quality, Service Technician engagement, sales, and gross margins.…
30d+
Sedgwick County, KS
3.4
Children and Family Health Director - HEALTH DEPT.
Wichita, KS
$74K (Employer provided)
Per Sedgwick County policy, this is a driving level position that requires a valid Kansas driver’s license without restrictions and current proof of automobile……
30d+
Victaulic
3.4
Engineering Manager, Tools Technology
Easton, PA
$91K - $129K (Glassdoor est.)
This role leads the mechanical development of new pipe preparation tools — spanning roll grooving, cut grooving, hole cutting, and specialty tools — as well as……
26d
Interborough Developmental and Consultation Center
3.1
Critical Time Intervention (CTI): Licensed Mental Health Professional
Brooklyn, NY
$75K (Employer provided)
Easy Apply
The licensed clinician must possess and maintain an active license with a master’s degree in the human services field such as social work or mental health……
30d+
NewPath Child & Family Solutions
3.3
Behavioral and Mental Health Clinical Educator
Cincinnati, OH
$62K - $86K (Glassdoor est.)
Easy Apply
Must be least 21 years of age, have a valid driver's license, and proof of current automobile insurance. Independent Professional license (LPCC required) in……
30d+
Alliance on Aging
Finance Manager
Salinas, CA
$120K - $150K (Employer provided)
Easy Apply
Prepare financial reports for federal, state, county, and local funding agencies. Experience with federal, state, county, and local government funding.…
16d
Family Services
3.0
Child & Adolescent Clinician (LMSW, LCSW, LMHC)
Kingston, NY
$60K - $75K (Employer provided)
Easy Apply
Provide diagnostic evaluations and develop tailored treatment plans for children, adolescents, and their families, focusing on both individual and family……
30d+
Valley Medical Center & Clinics
3.7
Nurse Manager Infusion and Immunotherapy Center | $10,000 Sign-on Incentive
Renton, WA
$147K - $220K (Employer provided)
Easy Apply
Bachelor’s degree required, preferably Nursing, Healthcare Administration, or other relevant field. Requires sound, independent judgment, initiative, and……
5d
State of Colorado
3.6
CDOC Food Service Supervisor CSTS I (Sterling)
Sterling, CO
$5,081 - $7,113 (Employer provided)
Eligibility to drive a State-owned vehicle, includes holding a valid Colorado driver’s license within 30 days of employment or residency change and meeting……
29d
Suburban Animal Hospital
3.4
Veterinarian, Medical Director
Rochester, NY
$180K (Employer provided)
Easy Apply
Active DEA license or DEA licensure eligible. Partnering with the practice manager and leadership team, you'll develop strategies, implement improvements, and……
30d+
Stone Ridge Veterinary Medical Center
Veterinarian, Medical Director
Rochester, NY
$180K (Employer provided)
Easy Apply
Active DEA license or DEA licensure eligible. Partnering with the practice manager and leadership team, you'll develop strategies, implement improvements, and……
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

23,995 Manager/Director Human Resources 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