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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.…
18d
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.…
18d
MU Health Care
3.6
Clinical Nurse Manager - Maternal Newborn - Children's Hospital
Columbia, MO
$109K - $178K (Employer provided)
When the primary state of residency changes, compact state RNs must apply under the new state of residency within thirty (30) days.…
30d+
Swope Health Services
3.2
Clinic Manager RN - Leavenworth Clinic
Leavenworth, KS
$80K (Employer provided)
Easy Apply
Completes Environmental Protection Agency (EPA) certification on bio hazardous waste and Department of Transportation (DOT) certification on transporting……
30d+
Amberwell Health
3.3
Director of Emergency Care
Hiawatha, KS
$57K - $97K (Glassdoor est.)
Ensures compliance with certification and accreditation standards in accordance with Amberwell policies and procedures. Ensures on going staff development.…
30d+
The Guthrie Clinic
3.8
Manager, Nursing - Post Anesthesia Care Unit - Full Time
Sayre, PA
Easy Apply
B. Integrates clinical, financial, and operational data and evaluates the impact upon patient clinical and financial outcomes. Up to a $25,000 Sign on Bonus.…
30d+
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+
Petaluma Health Center
3.9
Residency Program Director
Petaluma, CA
$128K - $176K (Employer provided)
Easy Apply
Current California license as an FNP. Communicate effectively with the patients while involved with their health care, including providing appropriate patient……
24h
Visiting Nurse Home & Hospice
3.8
Hospice Clinical Manager - FT, Excellent Pay & Benefits, Middletown, RI
Middletown, RI
$47.50 Per Hour (Employer provided)
Easy Apply
§484.115(c)* provides that a clinical manager must be a licensed physician, physical therapist, speech language pathologist, occupational therapist, audiologist……
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+
Mad River Community Hospital
3.0
Emergency Department Manager
Arcata, CA
$150K - $170K (Employer provided)
Easy Apply
Possesses a current license in the State of California. Possesses current BLS, ACLS, NRP and PALS certification. Bachelor of Science in Nursing preferred.…
30d+
UT Southwestern Medical Center
3.9
Senior Counsel, Medical Risk Management
Dallas, TX
$98K - $148K (Glassdoor est.)
Experienced Senior Counsel working under minimal supervision to lead a team of nurse risk managers within the Office of Legal Affairs responsible for handling a……
30d+
Sumner College
4.3
Clinical Instructor (Part-time)
Bend, OR
Easy Apply
Conduct instruction at clinical partner sites in Portland and the surrounding areas, working with groups of up to 8 students. Bachelor’s degree in Nursing.…
30d+
Clark-Lindsey
4.4
Nurse Manager (RN)
Urbana, IL
$82K - $97K (Employer provided)
Current, active Illinois Registered Nurse (RN) license. Directly supervise and support licensed nurses and nursing staff, providing clinical guidance and……
17d
The Manor at Blue Water Bay
3.3
Clinical Dietitian
Niceville, FL
$51K - $68K (Glassdoor est.)
Easy Apply
Thorough understanding of regulations (all local, state, and federal which apply/affect dietary and nutritional status, including patient care, sanitation,……
10d
Bethesda (MN)
3.0
Clinical Manager
Willmar, MN
$75K - $84K (Employer provided)
Easy Apply
Own vehicle, current valid driver’s license, and proof of current automobile insurance. Respond to calls received, assess the situation, and provide direction.…
10d
Casa San Jose
Bilingual Mental Health Coordinator
Pittsburgh, PA
$24.00 - $28.00 Per Hour (Employer provided)
Easy Apply
Bachelor's degree in psychology, sociology/social work or a related field from accredited institution OR at least three years of certified experience in social……
30d+
Connections Health Solutions
3.4
Licensed Clinical Supervisor (FT, Monday-Friday)
Kirkland, WA
$41.80 - $55.00 Per Hour (Employer provided)
Easy Apply
This role must hold an active Washington State-approved independent clinical license (e.g., Licensed Independent Clinical Social Worker (LICSW), Licensed Mental……
30d+
Career Land Center
4.5
Clinical Manager
San Francisco, CA
$77K - $119K (Glassdoor est.)
Easy Apply
Master’s degree in Social Work, Psychology, Counseling, or related field. The organization provides on-site supportive services within residential apartment……
30d+
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+
Concord Hospital
3.4
Nurse Manager | Medical Oncology & Medical Specialties
Concord, NH
$79K - $141K (Glassdoor est.)
The employee is occasionally exposed to airborne contaminants, chemotherapeutic agents, electrical hazards - shock, moving mechanical parts, non-weather related……
30d+
Good Samaritan
3.2
RN Case Manager, Home Health - Full Time
Saint Croix Falls, WI
$34.00 - $51.00 Per Hour (Employer provided)
Easy Apply
Depending on location, a valid drivers license may be required. Currently holds an unencumbered RN license with the State Board of Nursing where the practice of……
30d+
Trinity Health At Home
3.5
Home Health Registered Nurse, RN
Philadelphia, PA
Easy Apply
Must have current Driver’s license and reliable transportation. Licensure as a Registered Nurse in the state of PA. Health, dental and vision insurance.…
30d+
Andwell Health Partners
3.7
RN Case Manager Skilled Nursing
Lewiston, ME
$33.45 - $47.65 Per Hour (Employer provided)
Easy Apply
Active RN license in Maine. At least 1 year of clinical experience (home health is a plus, but heart matters just as much).…
30d+
Mad River Community Hospital
3.0
Director of Clinical Nursing
Arcata, CA
$160K - $180K (Employer provided)
Easy Apply
Current California Registered Nurse (RN) license in good standing. Master’s degree in Nursing, Healthcare Administration, or related field preferred.…
6d
Career Land Center
4.5
Laboratory Director
Alexandria, LA
$79K - $126K (Glassdoor est.)
Easy Apply
Current Medical Technologist state license. The director also works closely with hospital leadership and clinical teams to support patient care initiatives……
29d
First Call Home Health
3.3
Home Health Clinical Manager
Salem, OR
$125K (Employer provided)
Easy Apply
Current Registered Nurse (RN) license in the Oregon and CPR certification. Valid driver's license, reliable transportation, and proof of automobile insurance.…
21d
WVU Medicine
3.6
Director, ICU/Pathology - SMG
Morgantown, WV
$68K - $106K (Glassdoor est.)
Master’s degree in a Business, Healthcare Administration, Healthcare or related field AND Three (3) years of management or healthcare administrative experience……
30d+
Boothby Therapy Services
4.3
School Psychologist 10K Sign-On Bonus
Fryeburg, ME
$62.00 - $70.00 Per Hour (Employer provided)
Easy Apply
Support students' academic, social, emotional, and behavioral development. Design and implement evidence-based interventions and supports.…
7d
Rutland Regional Medical Center
3.5
Manager Education & Clinical Excellence
Rutland, VT
$107K - $156K (Employer provided)
Masters Degree in Nursing, Education, Healthcare Administration or related field required. Strong skill set in instruction design, adult learning theory and……
4d

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

83,764 Clinical development 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