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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.…
16d
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.…
16d
Ultragenyx
3.4
Associate Director, Production and Manufacturing Excellence
New Bedford, MA
$192K - $237K (Employer provided)
Bachelor's degree in science, engineering, or related field required. Provide strategic oversight and technical leadership for complex manufacturing……
5d
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+
Stellant
2.9
Director of Operations
Williamsport, PA
$100K - $153K (Glassdoor est.)
They will be a passionate, lean transformation champion with demonstrated success driving a “from scratch” transformation (both process and culture) and the……
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. Attends other meetings as necessary.…
30d+
Affinity Hospice
4.6
Executive Director - Full time
Madison, AL
$44K - $74K (Glassdoor est.)
Must be a licensed driver with an automobile that is insured in accordance with state and/or organization requirements and is in good working order.…
30d+
Stellar Senior Living
3.6
Director of Rehab - Skilling Nursing Community
Delta, CO
$90K - $120K (Employer provided)
Easy Apply
Must possess current and unencumbered license in Occupational Therapy, Speech Therapy, or Physical Therapy. Must have three to five years of clinical experience……
30d+
Paradigm Healthcare
3.9
Director of Nursing
Silsbee, TX
$80K (Employer provided)
Easy Apply
Ensure that staffing procedures include a sufficient number of licensed practical and/or registered nurses, certified nursing aides, and certified medication……
30d+
Pope’s Place
5.0
Rehabilitation Director (Physical Therapy)
Centralia, WA
$120K - $176K (Employer provided)
Easy Apply
A. Lead the design, implementation, and evaluation of rehabilitation program that address the needs of medically complex children and young adults.…
25d
Colonial Acres Nursing Home and Assisted Living
Director of Nursing
Humboldt, NE
$85K (Employer provided)
Easy Apply
In-depth knowledge of state-specific education laws related to healthcare training and certification requirements.…
9d
The Partners Care
Physician/Medical Director - Skilled Nursing Facility
Cranberry Twp, PA
$275K - $325K (Employer provided)
Easy Apply
MD or DO with an active and unrestricted medical license in PA. The ideal candidate is a board-certified or board-eligible physician with experience or strong……
29d
North Star Behavioral Health
2.1
Director of Risk Management
Anchorage, AK
$120K (Employer provided)
Easy Apply
*Education:* Bachelor’s degree in Social Sciences, Healthcare Administration, or a related field. UHS subsidiaries are equal opportunity employers and as such,……
12d
Access Medical Clinic
2.8
Physician Medical Director, Long Term Care
Savannah, GA
$210K - $384K (Glassdoor est.)
Easy Apply
MD or DO with active state medical license. Board certification in geriatric, family or internal medicine. Participate in monthly or quarterly QAPI meetings and……
30d+
Northeast Nebraska Community Action Partnership
2.5
Fiscal Officer/Finance Director
Pender, NE
$65K - $80K (Employer provided)
Easy Apply
QUALIFICATIONS/EDUCATION:* *Fiscal Officer/Finance Director* requires a bachelor’s degree in accounting, finance, business administration, or a related field.…
4d
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+
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+
Cedar Valley Hospice
4.2
Medical Director
Waterloo, IA
Easy Apply
Current unrestricted license to practice medicine in the State of Iowa required. Collaborate with the interdisciplinary team to develop and review patient plans……
10d
Confidential
Director of Rehabilitation
Oakland, CA
$67.30 - $76.90 Per Hour (Employer provided)
Easy Apply
Must possess and maintain a current license in the state of practice as required. PT, OT, or SLP license (Required). Skills applicable to clinical discipline.…
30d+
Journey (IN)
5.0
Director of Rehabilitation
Willoughby, OH
$77K - $102K (Glassdoor est.)
Easy Apply
Current license in Physical Therapy, Occupational Therapy, or Speech-Language Pathology. Overseeing compliance with all regulatory, licensing, and documentation……
30d+
Monarch Healthcare Management
4.0
Assistant Director of Nursing (ADON)
Faribault, MN
$83K - $98K (Employer provided)
Easy Apply
The Assistant Director of Nursing (ADON) supports the Director of Nursing by helping direct licensed and non-licensed staff to ensure high-quality resident care……
4d
Petaluma Health Center
3.9
Clinical Service Director, Vision
Petaluma, CA
$122K - $165K (Employer provided)
Easy Apply
Active State of California Optometrist license. The Director collaborates to ensure access to care, improve clinical quality, decrease clinical risk, implement……
30d+
Restpadd
3.4
Director of Nursing
Ukiah, CA
$115K - $140K (Employer provided)
Easy Apply
Possession of a valid license to practice as a Registered Nurse in the State of CA. Possession of an appropriate California Driver license.…
19d
CSL Plasma
3.1
Director, Regional Ecosystem Lead (San Diego)
San Diego, CA
$232K - $284K (Employer provided)
And pursue board or committee memberships to influence industry direction and strengthen networks. Serve as a senior member of deal teams occurring in each……
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+
Team Rehabilitation
4.1
Clinic Director - Physical Therapist
Atlanta, GA
$90K - $110K (Employer provided)
Make sure that the clinic complies with all state and federal healthcare regulations. Lead, mentor, and develop clinic staff, fostering a collaborative and……
30d+
Trio Healthcare
3.0
Travel Director of Nursing
United States
Easy Apply
Must be able to direct, supervise and evaluate work activities of medical, nursing, technical, clerical, service, maintenance, and other personnel.…
23d
Parnell
Plant Director
Menomonie, WI
$140K - $165K (Employer provided)
Easy Apply
Bachelor’s degree in engineering, Operations, Supply Chain, Pharmaceutical Sciences, or a related field required; Reliable production output and service levels.…
16d
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,……
13d
Premier Senior Living
3.2
RESIDENT CARE DIRECTOR
Eden, NY
$70K - $85K (Employer provided)
Easy Apply
Apply Now! Start your journey with Premier Senior Living……
12d

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

124,492 Director, RX Service and Operations jobs in United States

Position Summary:

Work Model:

Responsibilities:

Requirements:

Physical Demand Requirements:

Base pay range

Working here doesn’t have to be a secret

Position Summary:

Work Model:

Responsibilities:

Requirements:

Physical Demand Requirements:

Base pay range

Working here doesn’t have to be a secret