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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.…
3d
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.…
3d
Shermco Industries
3.5
Director of Transformation
Irving, TX
$160K - $190K (Employer provided)
This role converts insights into action by driving disciplined execution, advanced analytics, and cross-functional collaboration to deliver measurable results.…
12d
Amberwell Health
3.4
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.…
19d
Piedmont Healthcare
3.5
Director - Surgical Services
Columbus, GA
$65K - $100K (Glassdoor est.)
Masters Degree in Nursing or related field Preferred. Bachelors Degree in Nursing, Business Administration, Healthcare Administration, or another related field……
30d+
CHSGa
3.9
Director of Nursing
Dahlonega, GA
$78K - $102K (Glassdoor est.)
Attends and participates in continuing educational programs to keep abreast of changes in your field as well as to maintain current license/certification, as……
18d
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……
8d
State of Washington
3.4
Facility Medical Director - AHCC
Airway Heights, WA
$130K - $338K (Employer provided)
Unrestricted license to practice medicine in Washington State. Board certification in the ABMS/ABOM certified specialty with Internal Medicine preferred.…
30d+
Illuminus
2.4
RN, AL Director (LALD SPONSORED)
Chaska, MN
$88K - $109K (Employer provided)
Easy Apply
Current Registered Nurse (RN) license. Performs social service functions with advanced medical directives; guardianships; provision of social and emotional……
30d+
The McGuire Group
2.7
Director of Dietary Services
Roscoe, NY
$59K - $62K (Employer provided)
Easy Apply
Collaborate with clinical teams on nutrition and care plans. Oversee daily dietary operations and staff. Ensure compliance with NYSDOH/CMS and food safety……
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.…
9d
Lincoln Street
Director of Nursing
Springfield, VT
$90K (Employer provided)
Easy Apply
Maintain nursing license in the State of Vermont. Develop and maintain positive, professional and respectful relationships with individuals served, supervisor,……
30d
Mays Housecall
3.5
Director of Nursing (DON) - Home Health
McKinney, TX
Easy Apply
Active RN license in applicable state. Valid driver’s license and reliable transportation. Supervise clinical staff and manage day-to-day office, clinical, and……
30d+
Whiteville Area Post-Acute Care Practice
Post-Acute Medical Director in Whiteville, NC
Whiteville, NC
$130K - $146K (Employer provided)
Our comprehensive clinical and operational leadership team will support your transition into our medical practice with a comprehensive 3-month onboarding……
30d+
Memphis Convalescent Center
Director of Rehabilitation ***$2,500 Sign on bonus**
Memphis, TX
Easy Apply
Deliver direct patient care in your licensed discipline (PT, OT, or SLP). Is a licensed Physical Therapist, Occupational Therapist, or Speech-Language……
30d+
WVU Medicine
3.6
Director, ICU/Pathology - SMG
Morgantown, WV
$68K - $106K (Glassdoor est.)
Bachelor’s degree in a Business, Healthcare Administration, Healthcare or related field AND Five (5) years of management or healthcare administrative experience……
30d+
Delaware Valley Residential Care
Medical Director
Warminster, PA
$2,500 - $3,500 (Employer provided)
Easy Apply
Medical Director must also be active in clinical practice that relates to the population served. Participate in active clinical practice relevant to brain……
20d
Healthcare Services Group
3.1
Food Service Director
Hurricane, WV
$42K - $58K (Glassdoor est.)
Certified Dietary Manager (CDM) certification preferred (or as required by state and county law). Represent HCSG positively through courteous and cooperative……
18d
Park Manor of Cypress Station
1.3
Director of Nurses
Houston, TX
$79K - $108K (Glassdoor est.)
Easy Apply
Registered Nurse (RN) license in good standing in Texas. The Director of Nurses will collaborate closely with interdisciplinary teams to develop and implement……
30d+
Lowell Community Health Center
3.3
Director of Behavioral Health
Lowell, MA
$150K - $175K (Employer provided)
Identify and pursue grant funding opportunities from HRSA, SAMHSA, state agencies, and private foundations; lead program design and narrative development.…
13d
AuST Manufacturing
3.9
Director of Technical Operations
West Valley City, UT
$96K - $146K (Glassdoor est.)
Easy Apply
You have personally designed and built automated manufacturing equipment — not supervised a vendor who built it, but done the mechanical design, electrical……
30d+
Okanogan Behavioral HealthCare
3.7
Director of Substance Use Disorder Services
Omak, WA
$38.13 - $38.94 Per Hour (Employer provided)
Easy Apply
E) Ensures adherence to agency, state and local policy and procedures relevant to SUD are followed, including participation in the developing and implementation……
15d
Southeastern College
3.1
Program Director Radiologic Technology
United States
Easy Apply
Follow-up with students who miss a class (phone calls). Delivering their own course lectures. BUSINESS CONTRIBUTIONS: Program Directors are responsible for……
30d+
New England Tractor Trailer School
2.5
Director of HVAC/R
Haverhill, MA
$90K - $100K (Employer provided)
Easy Apply
Ensure curriculum aligns with state licensing requirements and industry standards. The right candidate brings deep technical knowledge of HVAC/R systems, a……
30d+
Steele Memorial Medical Center
3.2
Director of Surgical Services
Salmon, ID
$85K - $114K (Glassdoor est.)
RN licensure required in the state of Idaho; BSN preferred. Current BLS and ACLS certification required. Provides technical consultation and support to Surgical……
24h
Confidential
Director of Nursing (DON)
Grand View, Cheboygan, MI
$73K - $110K (Employer provided)
Easy Apply
Current Registered Nurse (RN) license in good standing. Bachelor's degree in Nursing (BSN) required; Master's degree in Nursing or related field preferred.…
30d+
Missouri Ozarks Community Health
2.8
Medical Director
Ava, MO
$265K - $280K (Employer provided)
Easy Apply
Manage telephone triage protocols and utilization/risk management systems. Graduate of an accredited medical school; *physician licensed in the State of……
30d+
Steele Memorial Medical Center
3.2
Director of Patient Financial Services
Salmon, ID
Bachelor's degree in business Administration, finance, or related field along with 3-5 years of progressive experience in healthcare revenue cycle management……
6d
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+
The House of the Good Shepherd
3.2
DIRECTOR OF REHABILITATION
Lakewood, NJ
$115K - $120K (Employer provided)
Easy Apply
Current New Jersey state licensure as a Physical Therapist, Occupational Therapist, or Speech Language Pathologist.…
30d+

Ultragenyx

3.4

Executive Director, CMC QA

Novato, CA

$294K - $363K (Employer provided)

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this job description.

Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultraimpact – Make a difference for those who need it most

The Executive Director, CMC QA will provide strategic, operational, and technical quality leadership across all Ultragenyx programs inclusive of biologics, small molecule, gene therapy, and ASO. This leader will oversee CMC QA responsibilities spanning program QA and CMO QA for starting materials, drug substance, and drug product, ensuring phase-appropriate and commercially robust quality oversight from development through lifecycle management. The role will lead and develop a team of approximately 8–12 quality professionals, partner closely with Technical Operations, Product Development, Supply Chain, Regulatory, and Quality stakeholders, and represent CMC QA in governance forums, inspections, regulatory submissions, and external partner interactions.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

Set and execute the CMC QA vision, strategy, operating model, and priorities for External Operations across all Ultragenyx programs and modalities, including starting materials, drug substance, and drug product.

Lead, coach, and develop a high-performing team of approximately 8–12 staff members responsible for program QA and CMO QA oversight; establish clear accountabilities, resource plans, succession plans, and performance expectations.

Ensure external partners operate in compliance with FDA, EMA, ICH, and other applicable global regulatory requirements, Ultragenyx Quality standards, approved regulatory filings, quality agreements, and industry best practices.

Drive proactive, risk-based oversight of external manufacturing quality systems, including deviations, investigations, CAPAs, change controls, complaints, product impact assessments, APR/PQR/APQR, CPV, validation, and tech transfer activities.

Own or oversee quality risk management strategies for external operations, including risk profiles, risk controls, escalation pathways, quality metrics, scorecards, trend reviews, and continuous improvement plans for CMOs and critical suppliers.

Ensure robust CMO and supplier qualification, selection, onboarding, ongoing monitoring, and lifecycle governance in partnership with Technical Operations, Supply Chain, Regulatory, Inspection Management, and Quality Systems.

Lead and/or support health authority inspection readiness, pre-approval inspection readiness, CMO inspection support, due diligence assessments, and responses to inspection observations associated with CMC and external operations.

Provide Quality leadership for regulatory submissions and post-approval commitments, including review of relevant CMC sections for INDs, BLAs, MAAs, amendments, supplements, annual reports, and responses to health authority questions.

Develop, implement, and continuously improve CMC QA policies, SOPs, standards, governance processes, and scalable quality infrastructure to support rare and ultrarare disease product development, commercial supply, and portfolio growth.

Model and reinforce a culture of quality, accountability, collaboration, continuous improvement, and patient focus across internal teams and external partners.

Perform other duties as assigned.

Requirements:

Bachelor's degree in life sciences, engineering, pharmacy, chemistry, biotechnology, or a related discipline; advanced degree (MS, PharmD, PhD, or equivalent) preferred.

Typically 15+ years of progressive experience in pharmaceutical, biotechnology, biologics, gene therapy, small molecule, or related regulated industry, with significant experience in CMC Quality Assurance and external manufacturing oversight.

Typically 10+ years of leadership experience within a Quality organization in a FDA/EMA-regulated environment, including experience leading leaders or senior professionals and managing departmental priorities, budgets, and resources.

Demonstrated experience providing quality oversight for CMOs/CDMOs, critical suppliers, and/or outsourced GMP operations across clinical, launch, and commercial lifecycle stages.

Expert knowledge of global GMP requirements and expectations, including FDA, EMA, ICH Q7/Q8/Q9/Q10/Q11/Q12 as applicable, and experience with other regulatory authorities such as MHRA, PMDA, Health Canada, ANVISA, and/or other global agencies.

Strong technical understanding of CMC development and manufacturing across multiple modalities such as biologics, small molecules, oligonucleotides, gene therapy, mRNA, enzymes/proteins, or other advanced/novel therapeutics; direct experience with starting materials, drug substance, and drug product preferred.

Proven ability to lead CMC QA strategy for rapid development, rare disease, ultrarare disease, registration, launch readiness, and commercial operations in a matrixed and/or highly outsourced operating model.

Demonstrated expertise in quality agreements, supplier qualification, deviation/investigation approval, CAPA effectiveness, change control, validation, technology transfer, APQR/PQR, CPV, and quality metrics.

Experience supporting health authority inspections, PAI readiness, regulatory filings, responses to health authority questions, and inspection observation remediation.

Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.

Executive-level communication, influencing, negotiation, and stakeholder-management skills, with the ability to align senior leaders and external partners around pragmatic, compliant, patient-focused solutions.

Demonstrated ability to build, lead, engage, and develop high-performing teams through ambiguity, growth, and organizational change.

Experience with Veeva or other electronic Quality Management Systems preferred; proficiency with Microsoft Word, Excel, PowerPoint, Teams, and Project or equivalent tools required.

Ability to travel up to approximately 20–30% domestically and internationally to Ultragenyx sites, CMOs/CDMOs, suppliers, and regulatory or inspection-related activities, as business needs require.

Physical Demand Requirements:

Primarily office-based role using a computer, phone, and virtual collaboration tools for extended periods.

Ability to work in a hybrid environment and travel to Ultragenyx sites, external manufacturing partners, contract laboratories, supplier sites, and other business locations as needed.

Occasional entry into GMP manufacturing, warehouse, laboratory, or controlled environments may require use of personal protective equipment and adherence to site-specific gowning, safety, and access requirements.
Ability to sit or stand for extended periods and participate in meetings, inspections, walkthroughs, and partner visits.

#LI-KJ1 #LI-Hybrid

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

Generous vacation time and public holidays observed by the company

Volunteer days

Long term incentive and Employee stock purchase plans or equivalent offerings

Employee wellbeing benefits

Fitness reimbursement

Tuition sponsoring

Professional development plans

Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.

See company reviews

Base pay range

The minimum salary is $294K and the max salary is $363K.

$294K – $363K/yr (Employer provided)

$329K

/yr Median

Novato, CA

If an employer includes a salary or salary range on their job, we display it as "Employer Provided". If a job has no salary data, Glassdoor displays a "Glassdoor Estimate" if available. To learn more about "Glassdoor Estimates," see our FAQ page.

Working here doesn’t have to be a secret

3.4

Recommend to a friend
Approve of CEO
CEO: Emil Kakkis
154 Ratings

Ultragenyx

3.4

Executive Director, CMC QA

Novato, CA

$294K - $363K (Employer provided)

Ultragenyx

3.4

Executive Director, CMC QA

Novato, CA

$294K - $363K (Employer provided)

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this job description.

Why Join Us?

Be a hero for our rare disease patients

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultraimpact – Make a difference for those who need it most

Work Model:

Responsibilities:

Set and execute the CMC QA vision, strategy, operating model, and priorities for External Operations across all Ultragenyx programs and modalities, including starting materials, drug substance, and drug product.

Lead, coach, and develop a high-performing team of approximately 8–12 staff members responsible for program QA and CMO QA oversight; establish clear accountabilities, resource plans, succession plans, and performance expectations.

Ensure external partners operate in compliance with FDA, EMA, ICH, and other applicable global regulatory requirements, Ultragenyx Quality standards, approved regulatory filings, quality agreements, and industry best practices.

Drive proactive, risk-based oversight of external manufacturing quality systems, including deviations, investigations, CAPAs, change controls, complaints, product impact assessments, APR/PQR/APQR, CPV, validation, and tech transfer activities.

Own or oversee quality risk management strategies for external operations, including risk profiles, risk controls, escalation pathways, quality metrics, scorecards, trend reviews, and continuous improvement plans for CMOs and critical suppliers.

Ensure robust CMO and supplier qualification, selection, onboarding, ongoing monitoring, and lifecycle governance in partnership with Technical Operations, Supply Chain, Regulatory, Inspection Management, and Quality Systems.

Lead and/or support health authority inspection readiness, pre-approval inspection readiness, CMO inspection support, due diligence assessments, and responses to inspection observations associated with CMC and external operations.

Provide Quality leadership for regulatory submissions and post-approval commitments, including review of relevant CMC sections for INDs, BLAs, MAAs, amendments, supplements, annual reports, and responses to health authority questions.

Develop, implement, and continuously improve CMC QA policies, SOPs, standards, governance processes, and scalable quality infrastructure to support rare and ultrarare disease product development, commercial supply, and portfolio growth.

Model and reinforce a culture of quality, accountability, collaboration, continuous improvement, and patient focus across internal teams and external partners.

Perform other duties as assigned.

Requirements:

Bachelor's degree in life sciences, engineering, pharmacy, chemistry, biotechnology, or a related discipline; advanced degree (MS, PharmD, PhD, or equivalent) preferred.

Typically 15+ years of progressive experience in pharmaceutical, biotechnology, biologics, gene therapy, small molecule, or related regulated industry, with significant experience in CMC Quality Assurance and external manufacturing oversight.

Typically 10+ years of leadership experience within a Quality organization in a FDA/EMA-regulated environment, including experience leading leaders or senior professionals and managing departmental priorities, budgets, and resources.

Demonstrated experience providing quality oversight for CMOs/CDMOs, critical suppliers, and/or outsourced GMP operations across clinical, launch, and commercial lifecycle stages.

Expert knowledge of global GMP requirements and expectations, including FDA, EMA, ICH Q7/Q8/Q9/Q10/Q11/Q12 as applicable, and experience with other regulatory authorities such as MHRA, PMDA, Health Canada, ANVISA, and/or other global agencies.

Strong technical understanding of CMC development and manufacturing across multiple modalities such as biologics, small molecules, oligonucleotides, gene therapy, mRNA, enzymes/proteins, or other advanced/novel therapeutics; direct experience with starting materials, drug substance, and drug product preferred.

Proven ability to lead CMC QA strategy for rapid development, rare disease, ultrarare disease, registration, launch readiness, and commercial operations in a matrixed and/or highly outsourced operating model.

Demonstrated expertise in quality agreements, supplier qualification, deviation/investigation approval, CAPA effectiveness, change control, validation, technology transfer, APQR/PQR, CPV, and quality metrics.

Experience supporting health authority inspections, PAI readiness, regulatory filings, responses to health authority questions, and inspection observation remediation.

Strong quality risk management capability and proficiency with root cause analysis, risk assessment, trend analysis, and decision-making tools.

Executive-level communication, influencing, negotiation, and stakeholder-management skills, with the ability to align senior leaders and external partners around pragmatic, compliant, patient-focused solutions.

Demonstrated ability to build, lead, engage, and develop high-performing teams through ambiguity, growth, and organizational change.

Experience with Veeva or other electronic Quality Management Systems preferred; proficiency with Microsoft Word, Excel, PowerPoint, Teams, and Project or equivalent tools required.

Ability to travel up to approximately 20–30% domestically and internationally to Ultragenyx sites, CMOs/CDMOs, suppliers, and regulatory or inspection-related activities, as business needs require.

Physical Demand Requirements:

Primarily office-based role using a computer, phone, and virtual collaboration tools for extended periods.

Ability to work in a hybrid environment and travel to Ultragenyx sites, external manufacturing partners, contract laboratories, supplier sites, and other business locations as needed.

Occasional entry into GMP manufacturing, warehouse, laboratory, or controlled environments may require use of personal protective equipment and adherence to site-specific gowning, safety, and access requirements.
Ability to sit or stand for extended periods and participate in meetings, inspections, walkthroughs, and partner visits.

#LI-KJ1 #LI-Hybrid

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

Generous vacation time and public holidays observed by the company

Volunteer days

Long term incentive and Employee stock purchase plans or equivalent offerings

Employee wellbeing benefits

Fitness reimbursement

Tuition sponsoring

Professional development plans

Benefits vary by region and country

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

See company reviews

Base pay range

The minimum salary is $294K and the max salary is $363K.

$294K – $363K/yr (Employer provided)

$329K

/yr Median

Novato, CA

Working here doesn’t have to be a secret

3.4

Recommend to a friend
Approve of CEO
CEO: Emil Kakkis
154 Ratings

Are you open to new opportunities?

204,771 Director, Partner Integration 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