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
Béquet Confections
4.0
Operations Manager
Bozeman, MT
$80K - $111K (Employer provided)
Easy Apply
Bachelors’ Degree in a related field. Identify production constraints and bottlenecks, develop solutions, and implement changes in real-time to maximize output.…
2d
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
Martins Point Health Care
2.5
Senior Vice President, Operations - Remote
Portland, ME
$158K - $251K (Glassdoor est.)
Bachelor’s degree in Business Administration, Healthcare Administration, Finance, Public Health, or related field.…
2d
senior vice president operations manager jobs in Portland, ME Portland, ME jobs Martins Point Health Care jobs in Portland, ME
Martins Point Health Care salaries senior vice president operations manager salaries in Portland, ME
Employee reviews at Martins Point Health Care Martins Point Health Care interview experience Working at Martins Point Health Care
Tia
3.5
Vice President, Operations - Remote
Phoenix, AZ
$250K - $300K (Employer provided)
Easy Apply
Build the foundational operating infrastructure needed to scale a multi-state, multi-site clinical business, including consistent processes, performance rhythms……
30d+
vice president operations manager jobs in Phoenix, AZ Phoenix, AZ jobs Tia jobs in Phoenix, AZ
Tia salaries vice president operations manager salaries in Phoenix, AZ
Employee reviews at Tia Tia interview experience Working at Tia
Confidential
Biorepository Operations Director
Arlington, VA
Easy Apply
Bachelor’s degree in science, health science or another relevant field required. Potential exposure to bodily fluids, blood borne pathogens, electrical,……
30d+
Phoebe Putney
3.4
Manager of Labor Management
Albany, GA
$66K - $115K (Glassdoor est.)
Bachelor’s Degree in related field (Required). Maintain associated infrastructure to ensure that accurate and current data is available in productivity-based……
30d+
H. H. Dobbins
3.2
Maintenance and Sanitation Manager
Lyndonville, NY
$125K (Employer provided)
Easy Apply
Bachelor’s degree in mechanical, electrical, or industrial engineering, or related technical field preferred; equivalent technical training and experience will……
2d
Sitka Sound Science Center
Executive Director
Sitka, AK
$117K - $165K (Employer provided)
Easy Apply
Ensure field station facilities — classrooms, laboratories, dive spaces, salmon hatchery, and aquarium — are well maintained and that a facility master plan is……
30d+
ALUKO Group
4.1
Anodizing Manager
Halls, TN
$100K (Employer provided)
Easy Apply
Bachelor’s degree in Engineering, Manufacturing, Industrial Technology, or related field. Build and develop a strong production team during plant startup.…
30d+
Amazon
3.5
AMER DC Delivery Operations Program Manager , Infrastructure
Seattle, WA
$83K - $130K (Employer provided)
Bachelor's degree in Business Administration, Finance, Economics, Computer Science, Engineering, or related field.…
24h
Fluid Imaging Technologies
3.4
Quality and Supply Chain Manager
Scarborough, ME
$100K (Employer provided)
Easy Apply
Establish and monitor key quality metrics (e.g., yield, defects, field performance, customer complaints) and lead corrective and preventive actions (CAPA).…
30d+
AkzoNobel
3.7
North America Regional Freight Audit and Cost Control Lead - Global Manufacturer
Nashville, TN
$105K - $115K (Employer provided)
Easy Apply
Contribute to the design and implementation of standardized freight audit processes aligned with the global transport strategy and digital roadmap(SAP TM/BN4L).…
30d+
Ramsey Companies, Inc.
Director of Operations
Wapato, WA
$150K (Employer provided)
Easy Apply
10+ years of progressive leadership experience in fuel/petroleum distribution, wholesale marketing, or high-volume logistics, preferably with multi-state or……
30d+
Novolex
2.9
EHS Manager
Yakima, WA
$100K - $120K (Employer provided)
BS degree in safety, industrial hygiene, or environmental related discipline and 5+ years experience in EHS or related field.…
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+
Buzzi Unicem USA
3.4
Manager Strategic Commodities & Energy
Festus, MO
Bachelor's degree in Supply Chain Management, Business Administration, Finance, Engineering, or a related field; or equivalent relevant professional work……
30d+
Rite of Passage
2.8
Clinical Director (LCSW, LMFT, LPC)
Cheyenne, WY
$75K (Employer provided)
Easy Apply
Master’s degree in counseling, Psychology, Social Work, or related field (Doctorate preferred). The *Clinical Director *is also a public ambassador,……
30d+
Nicholas Meats
2.2
Harvest Superintendent
Loganton, PA
$65K - $79K (Employer provided)
Easy Apply
Proven experience in meat processing or a related field with a focus on food safety regulations. Trains and develops supervisors to provide management depth and……
21d
Amazon
3.5
Transmission System Manager, AWS Energy Team
Seattle, WA
$92K - $160K (Employer provided)
As a Transmission Systems Manager you will manage a portfolio of power flow analysis, due diligence and transmission studies using industry tools and in……
24h
Amazon
3.5
Data Center Project Manager, Critical Projects Implementation
Ashburn, VA
$111K - $186K (Employer provided)
The Project Manager is ultimately responsible for project oversight and review of all disciplines including electrical, mechanical, controls, and architectural.…
24h
Confidential
Licensed Nursing Home Administrator
Roseville, MN
$95K - $110K (Employer provided)
Easy Apply
A degree in healthcare, business, or related field is preferred. Knowledge of federal and state regulations. You ensure continuity and consistency in delivery……
19d
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……
24h
Avmax
2.9
Director of Quality - Great Falls Montana
Great Falls, MT
$106K - $160K (Glassdoor est.)
Demonstrated capability and competency in field of expertise. Participate in the establishment, organization, and implementation of short and long-term goals,……
30d+
Farmer Focus
3.7
Refrigeration Manager
Harrisonburg, VA
$60.00 Per Hour (Employer provided)
Easy Apply
CARO certification required; RETA CIRO certification highly preferred. Ability to interpret technical documents, schematics, and engineering drawings.…
30d+
TreeHouse Foods
2.9
Maintenance Manager
Cambridge, MD
$98K - $146K (Employer provided)
Bachelor's degree in engineering or related field is preferred. Strong knowledge of electronics, controls, mechanical and electrical components found in food……
30d+
SRM Concrete
2.6
Regional Training Manager
Johns Island, SC
$56K - $84K (Glassdoor est.)
Travel regionally to evaluate training effectiveness, provide coaching, and support field teams. Experience working with or understanding CDL drivers, trucking,……
30d+
Desco Corporation
3.0
Business Unit Manager- PCD/Medical
New Cumberland, WV
$53K - $88K (Glassdoor est.)
Easy Apply
Bachelor’s degree in engineering or related field, MBA preferred. Ability to develop and implement successful financial goals, marketing and business plans.…
26d
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+
WVU Medicine
3.6
Director, ICU/Pathology - SMG
Morgantown, WV
$68K - $106K (Glassdoor est.)
Bachelor’s degree in a Business, Healthcare Administration, Healthcare or related field AND Five (5) years of management or healthcare administrative experience……
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

492,515 Vice President, Field Operations 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