Notifications

Are you open to new opportunities?

Upload your resume to increase your chances of getting noticed.

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.…
6d
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.…
6d
Ultragenyx
3.4
US National Field Leader, Neurology
Novato, CA
$275K - $340K (Employer provided)
The National Field Leader will establish launch strategy for the field sales teams, performance drivers and the resourcing plans to support the Ultragenyx……
30d+
Novartis
4.0
Associate Director, Field Launch Excellence
Remote
$153K - $283K (Employer provided)
Build trusted partnerships across Product, Data & Analytics, Finance, Legal, Compliance, Marketing, and other matrix teams to enable effective field deployment……
5d
associate director field manager jobs in Remote Remote jobs Novartis jobs in Remote
Novartis salaries associate director field manager salaries in Remote
Employee reviews at Novartis Novartis interview experience Working at Novartis
argenx
3.2
GPS Quality Manager
Remote
$128K - $176K (Employer provided)
At least Bachelor’s degree in pharmacy, nursing, healthcare or other life-science or technical field or country equivalent combination of education and……
5d
quality manager jobs in Remote Remote jobs argenx jobs in Remote
argenx salaries quality manager salaries in Remote
Employee reviews at argenx argenx interview experience Working at argenx
Lynn Community Health Center
3.5
RN Manager
Lynn, MA
$80K - $95K (Employer provided)
Easy Apply
Participate in direct and indirect patient care for patients who have HIV, and/or HCV and/or TB or LTBI and/or Sexually Transmitted Infections, and/or Hepatitis……
30d+
GL Solutions
2.7
Technical Services Manager
Kalispell, MT
$84K - $96K (Employer provided)
Easy Apply
Oversee the design, development, and testing of strategic projects including ERP, dashboards, and workflow tools.…
29d
Finance Factors
3.2
Assistant Account Manager II
Honolulu, HI
$45K - $55K (Employer provided)
Easy Apply
Producer’s license in Property and Casualty. Provide relief for the receptionist as requested. Input customer information and policy details into AMS for new……
6d
North Fork Rancheria Indian Housing Authority
Occupancy Manager
North Fork, CA
$46K - $66K (Employer provided)
Easy Apply
Assists with phone calls and greeting walk-ins; Demonstrated skill in learning, interpreting, providing guidance on federal, state, and local laws, rules, and……
2d
Avera Health
4.0
Radiology Technologist
Gettysburg, SD
$26.75 - $40.00 Per Hour (Employer provided)
Easy Apply
Utilizes computer systems such as PACS, RIS, HIS EMR systems and performs general clerical duties. Assists with analysis, collection and maintenance of records……
30d+
Teck Resources Limited
4.0
Senior Engineer, Tailings and Closure
Idaho
$101K - $131K (Employer provided)
Provide rigorous contractor and consultant management, including scope development, budgeting, execution oversight, safety compliance, quality control, and……
9d
Denver Housing Authority
2.6
Commercial Portfolio Manager
Denver, CO
$89K - $112K (Employer provided)
Easy Apply
Must have a valid Colorado driver license. Must respond to after-hours emergency calls. Bachelor's degree in business, public administration, management, or……
6d
Concord Hospital
3.4
Nuclear Medicine Technologist | Full Time | Days | No Call!
Laconia, NH
$61K - $89K (Glassdoor est.)
Under the supervision of the Chief Nuclear Medicine Technologist, Director of Radiology, Chairman or Manager, the nuclear medicine technologist performs nuclear……
30d+
Pinnacle Emergency Medical Group
Physical Therapist Manager
Winnebago, NE
$135K - $150K (Employer provided)
Easy Apply
Current, unrestricted Physical Therapist license in Nebraska. Ensure compliance with all federal, state, and organizational regulations (including HIPAA and CMS……
24h
Wallis Companies
3.6
Lubes - Area Sales Manager
Winchester, VA
Enhance team accomplishments and competence by answering technical and procedural questions for less experienced team members, teaching improved processes, and/……
16d
DaVita
3.2
Clinical Services Manager (MCS)
Indianapolis, IN
Current driver’s license, reliable transportation, and vehicle insurance in the state of residence. Education to commensurate with RN license.…
30d+
MaineHealth
3.7
Manager - Rehabilitation Services
North Conway, NH
$74K - $97K (Glassdoor est.)
License/Certifications: Current state licensure in physical therapy, occupational therapy or speech therapy required.…
30d+
North Star Behavioral Health
2.1
Dietary Manager
Anchorage, AK
$31.70 Per Hour (Employer provided)
Easy Apply
The Dietary Manager manages the food service and nutrition departments to ensure the implementation of standards for quality food service as they apply to……
30d+
Carpenter Technology
3.1
Manager - Metallurgy Special Projects
Reading, PA
$82K - $125K (Glassdoor est.)
Works with Metallurgy Leadership Team to develop knowledge and skills in the areas of strategy/plan development and alignment as well as leadership of broad……
30d+
Alvogen
3.3
Production Manager - 3rd Shift
Norwich, NY
$85K - $95K (Employer provided)
Easy Apply
BS in a technical discipline or equivalent education/technical work experience. Guide, monitor and develop team to foster continuous improvement.…
30d+
Atlas Roofing
3.8
Industrial Maintenance Manager/Plant Engineer
Camp Hill, PA
$68K - $96K (Glassdoor est.)
Easy Apply
Degree in manufacturing engineering or equivalent manufacturing maintenance specific technical school. Ten (10) years of relevant manufacturing experience……
30d
Catalent Pharma
2.8
Project Manager - Engineering
Madison, WI
$96K - $133K (Glassdoor est.)
This position will work on complex project controls activities that will require good organization skills, effective meeting leadership and contractor/vendor……
30d
INYA Inc.
Senior Environmental Project Manager (PE/PG)
San Diego, CA
$140K - $190K (Employer provided)
Easy Apply
Valid driver's license and ability to travel to project sites, client meetings, and field locations as needed. Must be authorized to work in the United States.…
20d
ASML
4.0
Electrical Safety & Compliance Manager
Wilton, CT
$105K - $148K (Glassdoor est.)
BS in engineering or in relevant technical field. MSc or PhD preferred in relevant technical field. Continuously improve and develop the specific engineering……
24h
Agropur
3.8
Maintenance Tech (Nights)
Le Sueur, MN
$30.19 Per Hour (Employer provided)
Easy Apply
Provide emergency/unscheduled repairs of mechanical, electrical, pneumatic and hydraulic equipment during the production process as needed.…
30d+
Kearney & Company
4.2
Audit Manager (TS/SCI w/ Poly Required)
Fort Meade, MD
$77K - $125K (Employer provided)
Bachelor's degree in Accounting or relevant business or technical field. Certified Public Accountant (CPA) certification. Prepare and implement audit program.…
30d+
Cadre
4.6
Warranty Manager – Locomotive Commissioning
Boston, MA
$84K - $117K (Glassdoor est.)
Collaborate with engineering teams to identify design improvements based on field experience. The Warranty Manager acts as the primary on-site technical……
30d+
American Medical Facilities Management
3.9
Director of Nursing (DON)
Derry, NH
$125K - $135K (Employer provided)
Easy Apply
Registered Nurse in good standing with required current New Hampshire license. Plan, develop, organize, implement, evaluate and direct the nursing services……
30d+
Northern Engraving
2.7
Sales Account Manager
Sparta, WI
Participate in new project cooperation throughout the entire process; support engineering design, prototype validation, mass production, and other phases;……
30d+
Balyo
3.9
Project Manager -Remote
Woburn, MA
$120K - $130K (Employer provided)
Easy Apply
3+ years of experience in a technical role: robotics, embedded software, automation, mechanical, or systems engineering.…
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

Are you open to new opportunities?

367,802 Request 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