Notifications

Are you open to new opportunities?

Upload your resume to increase your chances of getting noticed.

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
Ultragenyx
3.4
Director, Biostatistics
Novato, CA
$221K - $273K (Employer provided)
The Director of Biostatistics acts as program statistical lead; provides technical leadership and biostatistical support on the design and conduct of clinical……
4d
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+
Hayward Area Memorial Hospital
3.9
Director | Organizational Development & Learning | Full-Time
Ashland, WI
Easy Apply
Bachelor’s degree in Human Resources, Business, Organizational Development, Healthcare Administration or related field.…
30d+
Nemours Children's Health
3.7
Director, Value Analysis and Strategic Sourcing (RN)
Wilmington, DE
$68K - $107K (Glassdoor est.)
RN licensure within the state of Delaware or Florida, or multi-state Enhanced Nursing License Compact (eNCC). Lead enterprise Value Analysis program in pursuit……
4d
Cook Children's Health Care System
4.2
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+
Bond OpCo, LLC
Director of Account Management
Fort Lauderdale, FL
Aviation education (e.g., Embry-Riddle) and/or pilot certification is a strong plus. Own a portfolio of UHNW and corporate member relationships, serving as……
26d
Avera Health
4.0
Director Radiology
Easy Apply
Bachelor's Nuclear Medicine Technology, Business, Management or related field. Develops and updates policies and procedures consistent with organization’s……
11d
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
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). Sign-On Bonus: $25,000.…
9d
Palm Beach ACO, LLC
3.5
Regional Director - Northeast
Manhasset, NY
$80K - $100K (Employer provided)
Easy Apply
The Regional Director leads a team of state-level Market Managers and Provider Consultants, translating organizational strategy into measurable, on-the-ground……
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+
NaphCare
3.2
Medical Director
Brent, AL
$204K - $353K (Glassdoor est.)
Valid license as a physician in the state where the facility is located. Currently certified in a Board recognized by the American Board of Medical Specialties……
23d
Penfield Search Partners
5.0
Director Biostatistics - Oncology
San Francisco, CA
Easy Apply
They are currently seeking a highly skilled and experienced Director of Biostatistics to provide leadership to develop and execute statistical strategy, design……
30d+
Suffolk Construction
4.1
Director, Construction Contracts & Controls
Charlotte Amalie, VI
$112K - $155K (Glassdoor est.)
Provide commercial oversight of design-build delivery, ensuring alignment between design progression, contract milestones, and payment structures.…
30d+
Avmax
2.9
Director of Quality - Great Falls Montana
Great Falls, MT
$106K - $160K (Glassdoor est.)
Demonstrated capability and competency in field of expertise. Participate in the establishment, organization, and implementation of short and long-term goals,……
30d+
Legislative Council Service
Director
Santa Fe, NM
$123K - $236K (Employer provided)
Easy Apply
It provides bill drafting for all legislators, state agencies and public officers. The position includes a comprehensive benefits package available to all state……
18d
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+
NaphCare
3.2
Medical Director
Elmore, AL
Valid license as a physician in the state where the facility is located in AL. Currently certified in a Board recognized by the American Board of Medical……
30d+
Baptist Hospitals of Southeast Texas
3.1
Graduate Medical Education-Institutional Director-Days
Beaumont, TX
$49.29 - $65.73 Per Hour (Employer provided)
Easy Apply
Bachelor’s degree in Health Care, Health Care Administration or a related field. Implementation of system-wide improvements.…
12d
Wellpath
2.8
Site Medical Director
Cumberland, MD
$177.94 - $197.71 Per Hour (Employer provided)
We offer ongoing training and development opportunities for licensed and unlicensed healthcare team members, and have best in class clinical resources for……
30d+
Decatur County Hospital
3.0
Medical Director – Outpatient Clinic
Leon, IA
$300K (Employer provided)
Easy Apply
Active or eligible medical license in Iowa. Relocation + sign-on incentives (case-by-case). A dedicated clinical staff committed to patient-centered care.…
30d+
Sound Physicians
3.5
Hospitalist Medicine Program Medical Director | Academic Hospital Setting!
Fresno, CA
$375K (Employer provided)
H1B visa sponsorship available with dedicated in-house visa, licensing, and credentialing support. Comprehensive benefits package including paid malpractice,……
24h
Southern Maryland Tri-County Community Action Committee
1.4
Deputy Director of Housing and Community Development
Hughesville, MD
$95K - $124K (Employer provided)
Easy Apply
Bachelor’s degree in urban or Regional Planning, Real Estate Development, Civil Engineering, Public Administration, Business Administration, Community……
15d
Sound Physicians
3.5
Hospitalist Medicine Program Medical Director | 15 Minutes To Fresno!
Clovis, CA
$375K (Employer provided)
H1B visa sponsorship available with dedicated in-house visa, licensing, and credentialing support. Comprehensive benefits package including paid malpractice,……
24h
VUCC Admin
Regional Medical Director- Austin
Birmingham, AL
$160K - $180K (Employer provided)
Easy Apply
Current state licensure in good standing to practice. 6–12 Months: Strengthen collaboration across hospitals, support service expansion where appropriate, and……
24d
Lake Area Technical College
LATC Physical Therapist Program Director
Watertown, SD
$69K - $103K (Employer provided)
Easy Apply
Holds an active, unencumbered PT or PTA license/certification in any U.S. jurisdiction and in compliance with the state practice act in the jurisdiction of……
30d+
The Ohio State University Wexner Medical Center
3.7
Director - Histocompatibility Lab
Columbus, OH
$57K - $105K (Glassdoor est.)
This individual directs technological staff and works closely with attending physicians and fellows in both solid organ and bone marrow transplantation in the……
5d
Teck Resources Limited
4.0
Senior Engineer, Tailings and Closure
Idaho
$101K - $131K (Employer provided)
Provide rigorous contractor and consultant management, including scope development, budgeting, execution oversight, safety compliance, quality control, and……
5d

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?

176,948 Director, Implementation Consulting 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