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Ultragenyx
3.4
Executive Director, CMC QA
South San Francisco, CA
$294K - $363K (Employer provided)
Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.…
17d
Ultragenyx
3.4
Executive Director, CMC QA
Novato, CA
$294K - $363K (Employer provided)
Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.…
17d
Sacramento Children's Home
3.6
Clinical Supervisor (Licensed)
Sacramento, CA
$92K (Employer provided)
A valid driver’s license and minimum insurance coverage is also required. Must possess a license as an LMFT, LCSW, or LPCC. Knowledge of child abuse issues.…
30d+
University of Miami
3.8
Nurse Educator - CNOR & OR Experience Required Bascom Palmer Eye Institute, Miami, FL
Miami, FL
Valid State of Florida RN license required. Implements clinical skills activities within established clinical and preceptorship models, monitors data trends,……
30d+
State of Washington
3.4
Physician 3 - CRCC
Connell, WA
$246K - $331K (Employer provided)
Unrestricted license to practice medicine in Washington State. Unrestricted DEA license with waiver to prescribe buprenorphine for opioid use disorder.…
30d+
Ascension
3.5
Registered Nurse Oncology
Evansville, IN
$79K - $96K (Glassdoor est.)
Execute and adapt individualized care plans, vigilantly monitoring patient progress to ensure every clinical intervention is timely and effective.…
5d
Adagio Health
3.3
Travel Certified Registered Nurse Practitioner-CRNP
Pittsburgh, PA
$93K - $115K (Employer provided)
Easy Apply
Valid driver's license, reliable personal vehicle, and willingness to travel regularly throughout the regional network (required).…
30d+
State of Washington
3.4
Physician 3-Gender Affirming Care- CE69-HQ
Tumwater, WA
$209K - $281K (Employer provided)
Unrestricted license to practice medicine in Washington State. Unrestricted DEA license with waiver to prescribe buprenorphine for opioid use disorder.…
30d+
HCA Florida North Florida Hospital
2.9
Clin Nurse Coord Neuro
Gainesville, FL
$68K - $88K (Glassdoor est.)
Easy Apply
Education support through tuition assistance, student loan assistance, certification support, dependent scholarships and a partnership with Galen College of……
30d+
HCA Florida Fort Walton-Destin Hospital
3.3
RN Clinical Nurse Coordinator Trauma
Fort Walton Beach, FL
$70K - $91K (Glassdoor est.)
Easy Apply
Education support through tuition assistance, student loan assistance, certification support, dependent scholarships and a partnership with Galen College of……
15d
Shields Health Solutions
3.6
Specialty Pharmacist - 2nd Shift (1:00PM to 9:30PM EST)
Springfield, MA
$120K - $130K (Employer provided)
Easy Apply
Active Pharmacist license in the applicable state. Data entry and computer skills will be evaluated through an assessment as part of the pre-employment process.…
6d
Mary Free Bed Rehabilitation Hospital
3.9
Registered Nurse (RN) – Inpatient Acute Care Rotating Schedule
Grand Rapids, MI
$34.00 Per Hour (Employer provided)
Staff will provide patient care, treatment, and services within the scope of their license, certification or registration and as required by law and regulation.…
30d+
Mary Free Bed Rehabilitation Hospital
3.9
Registered Nurse (RN) – Inpatient Acute Care
Grand Rapids, MI
$36.00 Per Hour (Employer provided)
Staff will provide patient care, treatment, and services within the scope of their license, certification or registration and as required by law and regulation.…
30d+
Lowell General Hospital
3.7
RN - Certified Diabetes Educator
Lowell, MA
$40.53 - $51.67 Per Hour (Employer provided)
Manages own patient assignment by delegating and effectively based on patient needs and skills of team members. Exposure of blood-borne pathogens.…
30d+
U.S. Renal Care
3.5
Dialysis Facility Administrator
Chula Vista, CA
$111K - $166K (Employer provided)
Current RN license in applicable state. Assure that the clinic is in compliance with all applicable federal, state, and local laws and regulations and receives……
30d+
DaVita
3.2
Registered Dietitian
Springfield, OH
$52K - $69K (Glassdoor est.)
Easy Apply
Analyze lab-work results to educate patients and their families on what to eat based on their individualized needs and care.…
30d+
Ascension
3.5
Registered Nurse Med Surg
Mequon, WI
$81K - $105K (Glassdoor est.)
Licensure from the Wisconsin Board of Nursing OR current home state license if considered multi-state/Compact State. Long-term & short-term disability.…
30d+
Ascension
3.5
Registered Nurse CVICU
Evansville, IN
$79K - $99K (Glassdoor est.)
Deliver compassionate, high-quality nursing care that aligns with our gold-standard clinical protocols to ensure the highest levels of patient safety and……
30d+
Carilion Clinic
3.5
Clinical Dietitian (Cap I) - New River Valley Medical Center
Christiansburg, VA
$54K - $80K (Employer provided)
Collaborates with physicians and other members of the healthcare team to develop and implement evidence-based nutrition protocols, as well as educational……
30d+
Ascension
3.5
Registered Nurse Float Pool
Mequon, WI
$87K - $119K (Glassdoor est.)
Licensure from the Wisconsin Board of Nursing OR current home state license if considered multi-state/Compact State. Pediatric Advanced Life Support preferred.…
30d+
Ascension
3.5
Registered Nurse Float Pool
Mequon, WI
$87K - $119K (Glassdoor est.)
Licensure from the Wisconsin Board of Nursing OR current home state license if considered multi-state/Compact State. Pediatric Advanced Life Support preferred.…
30d+
Ascension
3.5
Registered Nurse ED
Mequon, WI
$87K - $115K (Glassdoor est.)
Licensure from the Wisconsin Board of Nursing OR current home state license if considered multi-state/Compact State. Schedule: Night Shift | Part-time.…
2d
Ensemble Health Partners
2.8
Patient Access Supervisor
Springfield, IL
$47K (Employer provided)
Easy Apply
Each associate will earn a professional certification relevant to their field and can obtain tuition reimbursement. Healthcare Supervisor: 2 years (Required).…
30d+
Allegheny Health Network
3.7
Medical Physicist I / Contract - AHN Cancer Institute Saint Vincent
West, TX
Master's Degree in Physics or related field from a CAMPEP-accredited program. Assists with special clinical research and development projects as assigned.…
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Bay Harbor Assisted Living
Director of Nursing RN
River Falls, WI
$80K - $100K (Employer provided)
Active RN license in Wisconsin required. Ensure compliance with Wisconsin RCAC regulations, state guidelines, and company policies.…
12d
The Partners Care
Physician/Medical Director - Skilled Nursing Facility
Cranberry Twp, PA
$275K - $325K (Employer provided)
Easy Apply
MD or DO with an active and unrestricted medical license in PA. The ideal candidate is a board-certified or board-eligible physician with experience or strong……
30d
Northfield Hospital & Clinics
3.6
Respiratory Therapist Lead
Northfield, MN
$39.48 - $55.73 Per Hour (Employer provided)
Easy Apply
Current RRT license with The National Board of Respiratory Care, in good standing. Current Respiratory Therapist license with the Minnesota Board of Medical……
30d+
Inland Imaging Business Associates
3.2
CT Technologist III
Spokane, WA
$37.88 - $56.82 Per Hour (Employer provided)
Easy Apply
Coordinates patient care between technologists and clerical staff to facilitate a smooth workflow. O Cleans exam room after each study.…
30d+
RieLes Group
Full Time CRNAs - Our Veterans in Atlanta, GA Need You!
Decatur, GA
$160.00 Per Hour (Employer provided)
Easy Apply
Graduation from an accredited nurse-anesthesia program. Collaborate with anesthesiologists, surgeons, nurses, and other clinical professionals.…
3d
HCA Florida North Florida Hospital
2.9
Clinical Nurse Coord Neuro
Gainesville, FL
$73K - $94K (Glassdoor est.)
Easy Apply
Education assistance (tuition, student loan, certification support, dependent scholarships). Whether you choose to focus on bedside care, a leadership or C-……
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

116,397 Clinical applications process 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