Notifications

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.…
12d
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.…
12d
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+
Calstart
3.2
Human Resources Coordinator
Remote
$29.81 - $35.77 Per Hour (Employer provided)
Associate’s degree in Human Resources, Business Administration, or related field; Bachelor’s degree preferred. Support HR audits and reporting requirements.…
12d
hr coordinator jobs in Remote Remote jobs Calstart jobs in Remote
Calstart salaries hr coordinator salaries in Remote
Employee reviews at Calstart Calstart interview experience Working at Calstart
Aspen One
4.2
Human Resources Manager - Aspen Snowmass
Aspen, CO
$65K - $85K (Employer provided)
Easy Apply
Keeps records and completes data entry of benefits plans participation such as insurance and retirement plan, personnel transactions such as hires, promotions,……
30d+
Condor Security of America
3.1
Staffing Coordinator (Temporary)
Salinas, CA
$23.00 - $25.00 Per Hour (Employer provided)
Easy Apply
Bachelor’s degree in Human Resources or related field preferred. Interviews candidates via telephone, video, and/or in person. Minimum of 2 years experience.…
30d+
Joseph Engineering
Finance Manager
Santa Maria, CA
$110K - $150K (Employer provided)
Easy Apply
Communication: Ability to read documents, view computer screens, and hear/speak during phone or video calls. Payroll knowledge, including wage/labor compliance……
22d
Visiting Nurses Home Care (NY)
4.6
RN Manager
Johnstown, NY
$90K - $95K (Employer provided)
Easy Apply
Valid New York State driver's license. Current, unrestricted Registered Nurse (RN) license in New York State. Unrestricted Registered Nurse (RN) license in New……
7d
Leaders Staffing
4.8
Bilingual Staffing Coordinator/Recruiter
Lafayette, IN
$20.00 - $23.00 Per Hour (Employer provided)
Easy Apply
Fill positions in manufacturing, warehouse, production, clerical, and light industrial environments. Experience supporting manufacturing, warehouse, logistics,……
26d
Grant 4-D Farms
Human Resources Assistant
Rupert, ID
$18.00 - $21.00 Per Hour (Employer provided)
Easy Apply
Create and maintain a currently employee driver’s license list for liability insurance. Various data entry as required. Full-Time- 40 Hours per week.…
3d
Southwestern WI Regional Planning Commission
Executive Director
Platteville, WI
$110K - $125K (Employer provided)
Easy Apply
Valid driver’s license and reliable transportation. Keep abreast of professional developments in the field through reading and attendance at conferences and……
24h
Hexin Technology
2.6
HRBP for Live Host (Bilingual in Mandarin)
Katy, TX
$4,000 - $5,000 (Employer provided)
Easy Apply
Bachelor’s degree in Human Resources, Business Administration, or a related field. Participate in the development and implementation of employee engagement……
5d
Landmark Construction (SC)
4.1
Project Manager- Heavy Civil Sitework
Charleston, SC
$76K - $107K (Glassdoor est.)
Easy Apply
Valid driver's license and ability to travel to project sites throughout the Southeast as required. Coordinate survey, layout, and grade control activities with……
11d
Corwin Automotive Group
3.3
Payroll/Human Resources Administrator
Reno, NV
$47K - $66K (Glassdoor est.)
Easy Apply
Performs all activities necessary to process payroll, including maintain related records, filing tax reports and voluntary deduction reports, processing……
8d
Byers Industrial Services
Bilingual Skilled Trades Recruiter
Franklinville, NJ
$50K - $73K (Employer provided)
Easy Apply
You will help build the workforce responsible for executing major industrial, manufacturing, commercial, and data center projects while working directly with……
30d+
PharmaLink
2.5
Bilingual HR Administrator - entry level ( Fully- on site)
Largo, FL
$37K - $53K (Glassdoor est.)
Easy Apply
Helps maintain compliance with federal, state, and local employment laws and regulations and recommended best practices in partnership with the HR Director with……
30d+
Huitt-Zollars
3.4
Senior Licensed Architect
Philadelphia, PA
$92K - $139K (Glassdoor est.)
Easy Apply
This role assists the design teams through all project phases including business and client development, programming, design and construction documents, and……
30d+
Nicolet Law Office
5.0
Recruiting Specialist
Eau Claire, WI
$46K - $63K (Glassdoor est.)
Easy Apply
High school diploma or equivalent (Bachelor’s degree in HR, Business Admin, or related field preferred). Manage incoming/outgoing mail and correspondence.…
6d
Briggs Nursery
4.1
HR Generalist
Elma, WA
$30.00 - $35.00 Per Hour (Employer provided)
Easy Apply
Assists with regulatory reporting and compliance with federal and state regulations. Manages DOT drug testing requirements and documents for CDL drivers.…
8d
RiverWoods
3.7
Dining Operations Manager -Full Time
Durham, NH
$41K - $53K (Glassdoor est.)
Bachelor’s degree in Hospitality Management, Food Service Management, Business, or a related field preferred; equivalent professional experience may be……
13d
Schwarzwaldmilch
1.0
Sr HR Generalist
Bellingham, WA
$80K - $90K (Employer provided)
Easy Apply
This Sr HR Generalist is responsible for setting the recruitment strategy for the Merchandising team and for building a strong partnership with the Regional……
15d
Hero Logistics
2.4
Human Resources Manager
Blue Springs, MS
$75K - $85K (Employer provided)
Easy Apply
*Education:* Bachelor’s degree in Human Resources, Business Administration, or a related field (Master’s degree preferred). SHRM-CP or SHRM-SCP preferred.…
15d
NorthEast Earth Mechanics, LLC
Human Resources Manager
Pittsfield, NH
$90K (Employer provided)
Easy Apply
This newly created position will own both functions end-to-end, partner closely with field and office leadership, and report directly to the CEO as a member of……
30d+
Aero Auto Repair
2.5
Human Resources Manager
Poway, CA
$70K - $90K (Employer provided)
Easy Apply
Bachelor’s degree in HR, Organizational Development, related field, or PHR/SHRM-CP Cert. preferred. Employee Relations – Listen to employees’ concerns and……
4d
Willoughby Industries
2.9
Talent Acquisition Specialist
Indianapolis, IN
$50K - $66K (Glassdoor est.)
Easy Apply
Work with department managers to develop and update job descriptions. Partner with marketing to promote hiring on social media sites, company websites, etc.…
24h
Alaska Mill & Feed
3.8
Human Resources Manager
Anchorage, AK
$80K - $95K (Employer provided)
Easy Apply
Possess a reliable personal vehicle, valid driver license and maintain a safe and insurable driving record. Navigate and coordinate leaves of absences and other……
30d+
Housing Works
3.1
Asset Protection Manager (Wicklander-Zulawski License required)
United States
$60K - $69K (Employer provided)
Easy Apply
Do you have a Wicklander-Zulawski license? Maintain professional and technical knowledge by attending training meetings/sessions and through independent study.…
30d+
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……
10d
Dynamic Nutraceuticals, LLC.
Bilingual Human Resources Generalist (English/Spanish)
Statesville, NC
$52K - $60K (Employer provided)
Easy Apply
Associate's degree in Human Resources, Business Administration, or related field required; Bachelor's degree in Human Resources, Business Administration, or……
24h
Slater Slater Schulman
2.8
Human Resources Coordinator
Melville, NY
$55K - $70K (Employer provided)
Easy Apply
Bachelor’s degree in Human Resources, Business Administration, or a related field (or equivalent experience). Serve as a point of contact for employee questions……
30d+

Ultragenyx

3.4

Executive Director, CMC QA

South San Francisco, 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

South San Francisco, 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

South San Francisco, CA

$294K - $363K (Employer provided)

Ultragenyx

3.4

Executive Director, CMC QA

South San Francisco, 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

South San Francisco, CA

Working here doesn’t have to be a secret

3.4

Recommend to a friend
Approve of CEO
CEO: Emil Kakkis
154 Ratings

12,043 Human Resources/Recruiting Manager/Office Manager jobs in United States

Position Summary:

Work Model:

Responsibilities:

Requirements:

Physical Demand Requirements:

Base pay range

Working here doesn’t have to be a secret

Position Summary:

Work Model:

Responsibilities:

Requirements:

Physical Demand Requirements:

Base pay range

Working here doesn’t have to be a secret