Notifications

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.…
13d
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.…
13d
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+
Kindred Hospitals
3.1
Director of Quality, Ethics, and Compliance - Kindred Hospital Indianapolis North
Indianapolis, IN
Easy Apply
Bachelor’s Degree in a healthcare-related field (required) _*And*_. RN - Registered Nurse - State Licensure and/or Compact State Licensure in the state of……
5d
Loyal Source
3.2
Clinical Director
Atlanta, GA
$200.00 Per Hour (Employer provided)
Easy Apply
Must have and maintain an unrestricted license from the Drug Enforcement Administration (DEA) to prescribe controlled medications in the state in which the duty……
30d+
CAMC Health
3.3
Senior Director of Quality
Morgantown, WV
$115K - $180K (Employer provided)
Easy Apply
Active Registered Nurse (RN) license required. Ensure compliance with federal, state, and accreditation standards.…
30d+
Takeda Pharmaceuticals
3.8
Associate Director, US Advertising & Promotion Regulatory Review
Boston, MA
$154K - $243K (Employer provided)
You will have a minimum of 5 years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years’ experience……
24h
BSA Health System
3.7
Director of Quality
Amarillo, TX
$101K - $143K (Glassdoor est.)
Current Texas RN license if applicant is a nurse. Bachelor’s degree in nursing, Healthcare Administration, or related clinical field.…
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+
Niagara Falls Memorial Medical Center
2.4
Lab Assistant Supervisor
Niagara Falls, NY
$75K - $95K (Employer provided)
Easy Apply
The successful candidate be responsible for the technical and/or direct supervision of laboratory associates and maintenance of policies, procedures, quality……
24h
Bethel Family Clinic
2.3
Quality Improvement / Quality Assurance / Compliance Registered Nurse (QI/QA RN)
Bethel, AK
$110K - $125K (Employer provided)
Easy Apply
Current, unrestricted *Registered Nurse (RN) license in the State of Alaska*. Alaska Board of Nursing and state regulations. Community health or public health.…
30d+
LifeWorks NW
2.7
Senior Clinical Administrative Director
Portland, OR
$44.50 - $64.22 Per Hour (Employer provided)
Easy Apply
Five years' experience in project implementation, management, coordination, progressively responsible clinical or administrative experience.…
30d+
Merit Health Natchez
3.4
Chief Quality Officer (CQO)
Natchez, MS
$55K - $103K (Glassdoor est.)
Easy Apply
5-7 years of direct experience in nursing, quality management, performance improvement, or a related field required. Complies with all policies and standards.…
24h
Armor Health
2.6
Medical Director
Altoona, PA
$150.00 - $155.00 Per Hour (Employer provided)
Easy Apply
Active Pennsylvania MD or DO license. Provide medical direction and clinical oversight for the facility's healthcare program. Board Certified or Board Eligible.…
24h
McGregor PACE
3.9
Quality Director
Cleveland, OH
$90K - $110K (Employer provided)
Easy Apply
Certified Professional in Healthcare Quality (CPHQ) certification preferred. Facilitating team decision-making using proven Pl/QI methodologies and tools.…
22d
Daiichi Sankyo
4.0
Senior Director, Clinical Safety Scientist
Basking Ridge, NJ
$243K - $405K (Employer provided)
The Senior Director plays a pivotal role in influencing safety governance, driving innovation in safety science, and ensuring regulatory and compliance……
30d+
Daiichi Sankyo
4.0
Director, Risk Based Quality Management (RBQM)
Basking Ridge, NJ
$202K - $303K (Employer provided)
Participate in CRO / vendor governance, ensure oversight of provider RBQM processes and tools and work collaboratively with partners to develop RBQM approaches.…
30d+
The GEO Group
2.9
CLINICAL DIRECTOR
Hagerstown, MD
$100K - $138K (Employer provided)
In partnership with the Quality Assurance and Training Department, ensures compliance with DPSCS state regulatory standards, accreditation standards, licensing……
30d+
Software Technology
4.2
Clinical Engineering Director
Zanesville, OH
$73K - $120K (Glassdoor est.)
Easy Apply
Oversee and manage all aspects of the clinical engineering program at Genesis Healthcare. Lead a team of supervisors and technical professionals, providing……
30d+
NeuroPsychiatric Hospitals
3.0
Director of Quality and Risk
Bremen, IN
$61K - $98K (Glassdoor est.)
The Director of Quality supports the implementation and monitoring of the quality assurance measurements and audits, and assists in improving patient safety……
20d
BioNTech
3.2
Director, Clinical Science
Cambridge, MA
$168K - $269K (Employer provided)
Lead the design of clinical trials by developing study protocols, identifying patient populations, selecting endpoints, and determining optimal study designs to……
9d
Carter Professional Care
2.5
Director of Quality Management & Grants
Syracuse, KS
$175K - $225K (Employer provided)
Easy Apply
This leadership position is responsible for developing, implementing, and evaluating organization-wide quality initiatives that improve patient outcomes, ensure……
24h
Daiichi Sankyo
4.0
Senior Director, Clinical Safety MD
Basking Ridge, NJ
$280K - $467K (Employer provided)
The Sr. Director, Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the……
30d+
Rogerson Communities
2.3
Director of Clinical Quality and Resident Care (RN license required)
Boston, MA
$135K - $150K (Employer provided)
Easy Apply
Registered Nurse (RN) required; bachelor’s degree in nursing or related field required. Coordinate and support state surveys, licensing visits and licensure……
2d
Aya Healthcare
3.4
Interim Apheresis Clinical Manager
Seattle, WA
Easy Apply
MLS, MT or SBB certification (Required). MLS(ASCP)CM, MT(ASCP), or SBB(ASCP) certification strongly preferred. Position:* Interim Apheresis Clinical Manager.…
8d
Eurofins
3.0
Lab QA Coordinator
Fairfield, OH
$55K (Employer provided)
Bachelor's degree in Biology, Business Management, or a related field required. Collaborate with laboratory operations, technical staff, and cross-functional……
2d
Grand River Aseptic Manufacturing
2.8
Regulatory Affairs Professional/Sr. Regulatory Affairs Professional
Grand Rapids, MI
$70K - $106K (Glassdoor est.)
Easy Apply
The Regulatory Affairs Specialist oversees regulatory affairs activities for the contract development and manufacturing organization (CDMO) where GRAM’s clients……
30d+
Covenant Health (Tennessee)
3.3
Vice President, Clinical Informatics,
Knoxville, TN
$105K - $170K (Glassdoor est.)
Employee must have a valid Tennessee driver’s license Class D and state mandated minimum insurance coverage. Actively participates in user groups and national……
30d+
Novartis
4.0
Associate Director, ADC platform in Oncology Drug Discovery
Cambridge, MA
$153K - $283K (Employer provided)
You will collaborate closely with cross-functional teams to design, evaluate, and advance next-generation ADC concepts with the goal of delivering……
21d
Purple Cow Recruiting
5.0
Director Quality Risk $110K–$150K Full Time Ottumwa IA
Ottumwa, IA
$110K - $150K (Employer provided)
Easy Apply
Bachelor’s degree in related field preferred (or equivalent experience). Integrate evidence-based practices into operations and clinical protocols.…
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

443,244 Associate Director, Clinical Quality 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