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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.…
8d
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+
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+
Confidential
Clinical Director
Anchorage, AK
$100K - $125K (Employer provided)
Easy Apply
Active, unrestricted clinical license (e.g., LCSW, LMHC, LPC, LMFT, PsyD, PhD) in the state of operation (required). Primarily onsite at Uris Hall.…
30d+
Amberwell Health
3.3
Director of Emergency Care
Hiawatha, KS
$57K - $98K (Glassdoor est.)
Ensures compliance with certification and accreditation standards in accordance with Amberwell policies and procedures. Attends other meetings as necessary.…
25d
Baptist Health System KY & IN
3.9
Director, Training and Development
Lexington, KY
$56K - $88K (Glassdoor est.)
Three (3) years’ healthcare teaching experience and program development in healthcare field. Master’s Degree in Nursing, Healthcare Education, Hospital……
28d
TapestryHealth
3.2
Regional Medical Director
Orlando, FL
$200K - $250K (Employer provided)
Easy Apply
MD or DO with an active medical license in multiple states within the assigned region (minimum of two required; additional state licensure strongly preferred).…
30d+
InnovAge
3.0
Physician Medical Director (Sign-on Bonus, Work-life Balance, Competitive Total Compensation)
Sacramento, CA
$371K - $415K (Employer provided)
All calls are first triaged by an RN with only a subset (< 10%) getting to the Physician for advice or orders (only phone support, no driving into center or……
30d+
Tucson Area Post-Acute Care Practice
PM&R Medical Director in Tucson, AZ
Tucson, AZ
$232K - $279K (Employer provided)
Our comprehensive clinical and operational leadership team will support your transition into our medical practice with a comprehensive 3-month onboarding……
30d+
State of Kansas
3.4
Clinical Director (PSP)
United States
$140K - $155K (Employer provided)
Maintain current knowledge of applicable standards and best practices, including those from the Centers for Medicare & Medicaid Services (CMS), The Joint……
30d+
The Partners Care
Physician/Medical Director - Skilled Nursing Facility
Newton, MA
$275K - $325K (Employer provided)
Easy Apply
MD or DO with an active and unrestricted medical license in Massachusetts. The ideal candidate is a board-certified or board-eligible physician with experience……
21d
Trio Healthcare
3.0
Travel Director of Nursing
Roanoke, VA
$80K - $101K (Glassdoor est.)
Easy Apply
Must be able to direct, supervise and evaluate work activities of medical, nursing, technical, clerical, service, maintenance, and other personnel.…
15d
Concentra
3.3
Physician Medical Director
Stockton, CA
$280K - $345K (Employer provided)
Easy Apply
State licensure requirements; unrestricted DEA license required. Leads collaboration within CLT for business outcomes, understands and contributes to financial……
11d
Adoration Health
4.1
RN / Director Of Clinical Operations - Hospice
Chattanooga, TN
$69K - $97K (Glassdoor est.)
Must be a licensed driver with an automobile that is insured in accordance with state and/or Organization requirements and is in good working order.…
30d+
Prime Source
Hospice Clinical Director
Albuquerque, NM
$105K - $110K (Employer provided)
Easy Apply
Hold current unencumbered license as a Registered Nurse. Performs chart audits while supervising the maintenance of medical records, assuring completeness and……
8d
Turnagain Community Health
Director of Nursing
Girdwood, AK
$47.47 - $56.97 Per Hour (Employer provided)
Easy Apply
Maintain current, active license with the State of Alaska as a Licensed Practical Nurse or Registered Nurse. Partners with the Administrative Practice Manager……
30d+
GoHealth Urgent Care
3.2
Regional Associate Medical Director | Physician Leader | - Sign on Bonus- $25,000
Des Peres, MO
Easy Apply
Minimum 2 years of clinical leadership or administrative experience in urgent care, emergency medicine, or related field (required). $25K Sign-On Bonus.…
15d
Cook Children's Health Care System
4.3
Director, Epilepsy Research
Fort Worth, TX
$60K - $102K (Glassdoor est.)
Cook Children's Director of Epilepsy Research is a core member of the Research team responsible for developing and leading a research program focused on……
30d+
AgeWell PACE
AgeWell PACE Medical Director
Rohnert Park, CA
$250K - $300K (Employer provided)
Easy Apply
M.D. or DO with current state of California license. Board certified in Internal Medicine or Family Practice with advanced certification in geriatrics,……
30d+
Cedar Valley Hospice
4.2
Medical Director
Waterloo, IA
$159K - $287K (Glassdoor est.)
Current unrestricted license to practice medicine in the State of Iowa required. Collaborate with the interdisciplinary team to develop and review patient plans……
2d
A and J Behavioral Health
4.0
Clinical Director
New York, NY
$95K - $117K (Employer provided)
Easy Apply
Oversee the management of clinical therapists/RBTS in the field. The ideal candidate will have a strong background in clinical oversight and a passion for……
30d+
Coast Ambulatory Surgery Center
Director of Nursing
Templeton, CA
$60.00 - $65.00 Per Hour (Employer provided)
Easy Apply
Oversee the implementation, organization, auditing, and maintenance of surgical charts to ensure accuracy and compliance with Medicare and AAAHC standards.…
30d+
CHRISTUS Health
3.5
Clinical Director- Cardio Cath Lab
Longview, TX
$93K - $165K (Glassdoor est.)
Easy Apply
RN license in good standing in state of employment or a compact state , if applicable. Master's degree in Nursing, Health Administration, Business……
30d+
The Bay at Burlington
3.0
Director of Therapy
Laona, WI
$130K (Employer provided)
Easy Apply
Recommend modifications or changes in the resident’s therapy program based on own evaluation of progress. Assume responsibility for ongoing continuing education……
14d
Bancroft
3.1
Clinical Director for Adults
Mullica Hill, NJ
$105K - $113K (Employer provided)
Valid driver’s license required in incumbent’s legal name and current address with no provisional restrictions. PhD in a related discipline desirable.…
30d+
The Waters
3.0
Director of Nursing
Rochester, MN
$110K - $120K (Employer provided)
Easy Apply
Knowledge of and maintain compliance with all Department of Health Regulations as it pertains to senior living communities with a comprehensive home care……
30d+
Ethos Veterinary Health
3.2
Hospital Director of Operations
Anchorage, AK
$130K - $160K (Employer provided)
Ideal Background: Proven experience building and scaling high-performing teams, driving engagement, and supporting professional development resulting in……
7d
Confidential
Executive Director - Hospice
Portland, OR
$135K - $145K (Employer provided)
Easy Apply
Supervise senior management staff, including nursing leadership, case managers, social workers, and administrative personnel.…
18d
The Brant Senior Living
1.2
Director of Nursing
Omaha, NE
$77K - $105K (Glassdoor est.)
Active RN license in state where working. Strong knowledge of state clinical practices, state and federal regulations pertaining to assisted living and/or……
3d
Florida Cancer Specialists & Research Institute
2.9
Area Director of Clinical Operations (North Florida area)
Gainesville, FL
Seven (7) years of experience or more in the healthcare field or clinic/outpatient setting with knowledge of Oncology required.…
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

Are you open to new opportunities?

274,701 Director, Clinical 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