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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.…
15d
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.…
15d
CAMC Health
3.3
Bioinformatician – Health Services & Outcomes Research
Charleston, WV
$58K - $70K (Employer provided)
Easy Apply
Master's degree in Informatics, Computer Science, or a related field. Doctorate in Informatics or a related discipline.…
15d
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+
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+
Phoebe Putney
3.4
Director, Imaging
Albany, GA
Master's Degree or other Degree in MBA, MHA, or related field (Preferred). Demonstrates technical skill in using equipment appropriate for role.…
30d+
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.…
8d
Post Acute NC
Medical Director/Attending Physician
Wilmington, NC
$65K - $320K (Employer provided)
Easy Apply
Active North Carolina medical license. Develop and implement clinical protocols and best practices. Provide clinical oversight and leadership within assigned……
30d+
Reliatus
5.0
Licensed Clinical Psychologist HSP Autism Assessment & Future Associate Director
Nashville, TN
$115K - $140K (Employer provided)
Easy Apply
*Licensure:* Active license as a *Psychologist in Tennessee with Health Service Provider (HSP) designation* (or highly eligible for reciprocity by May).…
30d+
Engineers & Surveyors Institute
Executive Director - Civil Engineering Membership Organization
Chantilly, VA
Easy Apply
Qualified candidates should be a licensed Professional Engineer, Surveyor or related discipline and have a minimum of 10 years demonstrated leadership and……
30d
Doctors For Providers
South Carolina Based Collaborating Physicians and Medical Directors (board certified US physicians)
South Carolina
$2K - $10K (Employer provided)
Easy Apply
Must reside in South Carolina and be licensed in the state of South Carolina.*. Looking for licensed and board certified physicians to be Medical Directors and……
30d+
Wellspring Cultural and Educational Foundation
3.6
Senior Clinical Director
Bethlehem, CT
$76K - $123K (Glassdoor est.)
Easy Apply
Acceptable credentials include PhD, PsyD, LCSW, LMFT, LPC, or other appropriate advanced clinical license. Mentor and develop clinicians through supervision,……
15d
Hunter Communications (OR)
3.3
Director of Engineering
Eugene, OR
$118K - $198K (Glassdoor est.)
Easy Apply
Valid driver’s license and safe driving record. This position requires a hands-on leader who can effectively develop and manage Engineering, GIS, and Planning……
17d
Precision Armament
Director of Compliance
Wellsville, NY
$65K - $90K (Employer provided)
Easy Apply
Valid driver’s license and ability to travel between Company facilities as needed. Overseeing firearm-related compliance, including ATF records, A&D records,……
9d
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+
The Hume Center
3.1
Community Clinical Program Director (aka Director of Clinical Community Programs)
Concord, CA
$129K - $160K (Employer provided)
Easy Apply
Be willing to use your own cell phone to be accessible and willing to be available to receive calls for crisis and/or emergency situations with supervisors and……
23d
SpringHealth Behavioral Health and Integrated Care
3.5
CLINICAL DIRECTOR - HYBRID
Jefferson City, MO
$80K (Employer provided)
Ensure all key performance indicators are tracked on a regular basis to identify proficiencies/deficiencies within the line (i.e., productivity, assessment due……
30d+
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. Collaborate with department leaders and medical staff to……
12d
UT Southwestern Medical Center
3.9
Sr. Director, Ambulatory RNs
Dallas, TX
$103K - $142K (Glassdoor est.)
Ensures top-of-license practice across all clinical roles. Ensures nursing practice aligns with state licensure, regulatory standards, and evidence-based……
29d
Dukes Memorial Hospital
3.3
Director ICU & MedSurg
Peru, IN
$74K - $133K (Glassdoor est.)
Easy Apply
Collaborates with interdisciplinary teams to develop and implement patient care strategies. Bachelor's Degree in relevant field required or.…
8d
Autism Learning Partners
3.0
Associate Clinical Director (BCBA)
Albany, NY
$100K (Employer provided)
Easy Apply
Master’s Degree or higher in Applied Behavior Analysis, Psychology, or a related field required. Collaborate with senior leaders to develop regional business……
30d
Wake Technical Community College
3.8
Director, Fire & Rescue Services
Raleigh, NC
$75K - $112K (Employer provided)
Ensures compliance with all applicable state and federal laws, certification standards, and safety regulations. Master’s degree in a related field.…
30d+
Autism Learning Partners
3.0
Associate Clinical Director (BCBA)
Valatie, NY
$100K (Employer provided)
Easy Apply
Master’s Degree or higher in Applied Behavior Analysis, Psychology, or a related field required. Collaborate with senior leaders to develop regional business……
30d+
Ascend Medical
Corrections Chief Medical Director $332K/Yr
Staunton, VA
$332K (Employer provided)
Easy Apply
Current, full, unrestricted license to practice medicine in the Commonwealth of Virginia or eligible for license (must obtain within 3 months of employment).…
30d+
Centurion Health
3.1
Part-time Site Medical Director - Illinois River Correctional Center
Canton, IL
$135.00 Per Hour (Employer provided)
Easy Apply
Active, unrestricted MD/DO Illinois license or ability to obtain. The Medical Director provides the clinical direction needed to meet service delivery……
30d+
CSL Plasma
3.1
Senior Director, Search & Evaluation Late TA Lead, Immunology
Waltham, MA
$263K - $328K (Employer provided)
NPO meetings are strategic checkpoints where cross-functional teams review potential assets identified by Search and decide whether to advance them for further……
30d+
Outer Cape Health Services
3.6
Site Medical Director
Harwich Port, MA
$105K - $255K (Employer provided)
Easy Apply
Possess and maintain a valid and unrestricted license to practice in the Commonwealth of Massachusetts. Work with the Senior Medical Director for Clinical……
10d
Prism Vision Group
2.7
ASC Director of Nursing
Spokane, WA
$93K - $193K (Employer provided)
Plans and organizes activities related to specific clinical services to ensure patient needs are met in accordance with all professional standards such as state……
9d
MBC BioLabs
Head of Environmental Health and Safety
San Francisco, CA
$100K (Employer provided)
Easy Apply
You will own the day-to-day coordination of safety programming, documentation, vendor relationships, and regulatory reporting across five (soon six) Bay Area……
29d

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

169,963 Director, Statistics 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