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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
Ultragenyx
3.4
Associate Director, Production and Manufacturing Excellence
New Bedford, MA
$192K - $237K (Employer provided)
Bachelor's degree in science, engineering, or related field required. Provide strategic oversight and technical leadership for complex manufacturing……
4d
Jackson Community College
3.0
Vice President of Human Resources
Jackson, MI
$160K - $180K (Employer provided)
If not currently certified, the successful candidate must be willing to pursue certification. Collaborate with the President, Executive Council, Academic……
13d
StandardAero
3.2
Human Resources Director - Component Repair Services (OH and VT)
Cincinnati, OH
$49K - $75K (Glassdoor est.)
3+ years of experience developing and deploying initiatives supporting workforce strategy & organization design, strategic organizational change management,……
25d
CFS
4.2
Human Resources Manager
Worcester, MA
$85K - $100K (Employer provided)
SHRM certification or experience in Paylocity is a plus but not required. Assist with policy development and implementation.…
7d
Confidental Company
Senior Human Resources Manager
Jupiter, FL
$130K - $155K (Employer provided)
Bachelor’s Degree in Human Resources, Psychology, or a related field. Drive compliance with employment laws and company policies, staying up to date with……
30d+
Confidental Company
Human Resources Manager - Senior
Stuart, FL
$130K - $155K (Employer provided)
Bachelor’s Degree in Human Resources, Psychology, or a related field. Drive compliance with employment laws and company policies, staying up to date with……
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:……
4d
Baker Concrete Construction
4.1
Human Resources Coordinator r
Monroe, OH
$42K - $56K (Glassdoor est.)
The Human Resources Coordinator is responsible for supporting and conducting HR Department initiatives including but not limited to employment compliance and……
23d
Amrize
2.5
Human Resources Manager
Bloomsdale, MO
$62K - $92K (Glassdoor est.)
Supports the HR Director through implementation of HR strategy to assure appropriate employee resources are available to achieve planned results.…
24d
Red Zone HR Solutions
Site Manager – Chemical Manufacturing
Proctor, WV
$190K - $220K (Employer provided)
Easy Apply
Strong knowledge of continuous-process chemical manufacturing, plant operations, maintenance and reliability, process safety, environmental compliance,……
9d
Zelle
4.1
Human Resources Consultant
Lincoln, NE
$68K - $104K (Glassdoor est.)
Easy Apply
Bachelor’s degree in Human Resources, Business Administration, or related field, preferred. Ensure all client HR practices comply with federal, state, and local……
30d+
TurnAround
2.9
Program Manager, Human Trafficking Services (2 Years Experience Required)
United States
$65K - $70K (Employer provided)
Easy Apply
Must have valid driver’s license and provide personal vehicle. Management level positions may receive call after hours on occasion which may include providing……
30d+
CVS Health
3.2
Care Management Coordinator - Field - OhioRISE Central/SE Ohio
Columbus, OH
$21.10 - $40.90 Per Hour (Employer provided)
2+ years of experience in children's mental health, child welfare, developmental disabilities, juvenile justice, or a public sector human services or behavioral……
30d+
Ascend Federal Credit Union
3.2
Senior Talent Management & Engagement Partner
Tullahoma, TN
Develop tools, resources, and coaching strategies that enable leaders to conduct meaningful performance conversations and effectively develop their teams.…
8d
CVS Health
3.2
Care Management Coordinator OhioRISE - Field - Northeast/Northwest Region Ohio
Columbus, OH
$21.10 - $40.90 Per Hour (Employer provided)
2+ years of experience in children's mental health, child welfare, developmental disabilities, juvenile justice, or a public sector human services or behavioral……
24d
CVS Health
3.2
Care Management Coordinator OhioRISE - Field - Central/SE Ohio
Columbus, OH
$21.10 - $40.90 Per Hour (Employer provided)
2+ years of experience in children's mental health, child welfare, developmental disabilities, juvenile justice, or a public sector human services or behavioral……
24d
CVS Health
3.2
Case Management Coordinator - Field - OhioRISE Northeast/Northwest Ohio
Columbus, OH
$21.10 - $40.90 Per Hour (Employer provided)
2+ years of experience in children's mental health, child welfare, developmental disabilities, juvenile justice, or a public sector human services or behavioral……
24h
IEH Laboratories & Consulting Group
2.6
Human Resources Manager (Lake Forest Park, WA)
Lake Forest Park, WA
$90K - $150K (Employer provided)
Proactively guide the business through compliance with federal, state, and local employment laws, including advising on evolving legislative developments (……
4d
CVS Health
3.2
Care Management Coordinator OhioRISE – Field – Must reside NW/West Region of Ohio
Columbus, OH
$21.10 - $40.90 Per Hour (Employer provided)
2+ years of experience in children's mental health, child welfare, developmental disabilities, juvenile justice, or a public sector human services or behavioral……
24d
Motiva
4.1
Regional Human Resources Business Partner (RHRBP)
Roanoke, VA
$70K - $80K (Employer provided)
Build HR Manager capability through regular field partnership sessions focused on skill development and strategic alignment.…
30d+
StandardAero
3.2
Senior HR Operations Manager - Component Repair Services
Cincinnati, OH
$53K - $78K (Glassdoor est.)
Bachelor’s degree in Human Resources, Business Administration, or related field. Master’s degree in in Human Resources, Business Administration, or related……
4d
BioAgilytix Labs
2.9
Manager, Project Management
Durham, NC
$78K - $118K (Glassdoor est.)
Easy Apply
Bachelor's degree in life science or related field with not less than eight (8) years’ experience in a biotechnology project management or related field; or.…
14d
CVS Health
3.2
Care Management Coordinator - Field - OhioRISE Central/SE Ohio
Columbus, OH
$21.10 - $40.90 Per Hour (Employer provided)
2+ years of experience in children's mental health, child welfare, developmental disabilities, juvenile justice, or a public sector human services or behavioral……
24d
Hanover Hill Health Care Center
3.7
Human Resources Director
Manchester, NH
$78K - $125K (Glassdoor est.)
Easy Apply
Extensive experience in the HR field may be considered in lieu of Bachelors degree. Performs all Human Resources activities of Hanover Hill to ensure facility……
16d
City of Columbus (Indiana)
4.4
Resource Development Manager
Columbus, IN
$47K - $61K (Employer provided)
The City of Columbus and Parks and Recreation has collaborated with Columbus Regional Health to develop the former Fair Oaks Mall into a health and wellness hub……
4d
Sonaca
3.2
Manager - Operations
Tulsa, OK
$135K - $150K (Employer provided)
Easy Apply
Prior experience in bid and proposal estimates, tooling design and manufacture, prototype production, manufacturing process improvement, and capital equipment……
30d+
Hologic
3.5
Senior Manager, Procurement
Marlborough, MA
$127K - $211K (Employer provided)
 Perform market analysis, benchmarking, total cost modeling, and spend analysis within assigned scope. Bachelor's degree required in Business, Engineering, or……
30d+
StandardAero
3.2
Human Resources Director - Component Repair Services (MO, AZ, FL, and CO)
Kansas City, MO
$47K - $70K (Glassdoor est.)
3+ years of experience developing and deploying initiatives supporting workforce strategy & organization design, strategic organizational change management,……
25d

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

47,171 Human Resources Manager - Term 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