Notifications

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.…
12d
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.…
12d
Ultragenyx
3.4
Associate Director, Global Medical Communications
Novato, CA
$191K - $236K (Employer provided)
Collaborate with Medical Information and other Medical Affairs colleagues to ensure scientific accuracy and message consistency across standard responses,……
30d+
Monogram Health
2.5
Market Physician Executive (MPE)
Valdosta, GA
$189K - $353K (Glassdoor est.)
Easy Apply
Active, unrestricted state medical license required in each state within the market. Current state medical license without restrictions to practice and free of……
30d+
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+
Signet Health
3.3
Director of Behavioral Health / Licensed Therapist (LCSW or LCPC)
Fort Kent, ME
$110K - $115K (Employer provided)
Ensuring compliance with hospital, state, federal, and licensing agency regulatory standards. Maine clinical licensure as a master’s level Social Worker (LCSW)……
28d
Monogram Health
2.5
Market Physician Executive (MPE) - Atlanta, GA
Atlanta, GA
$196K - $366K (Glassdoor est.)
Easy Apply
Active, unrestricted state medical license required in each state within the market. Current state medical license without restrictions to practice and free of……
30d+
Monogram Health
2.5
Market Physician Executive (MPE) - Float
Georgia
Easy Apply
Active, unrestricted state medical license required in each state within the market. Current state medical license without restrictions to practice and free of……
30d+
The Guthrie Clinic
3.8
Manager, Nursing - Post Anesthesia Care Unit - Full Time
Sayre, PA
Easy Apply
B. Integrates clinical, financial, and operational data and evaluates the impact upon patient clinical and financial outcomes. Up to a $25,000 Sign on Bonus.…
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.…
15d
Axe Staffing & Recruiting
4.3
Medical Director
Westbury, NY
$280K - $325K (Employer provided)
Easy Apply
Adult Psychiatry certification is required; Child and Adolescent Psychiatry experience or certification is considered a strong asset.…
7d
New Life Treatment Center (MN)
LPCC (Licensed Professional Clinical Counselor)
Woodstock, MN
$75K - $95K (Employer provided)
Easy Apply
A minimum of a master’s degree in a behavior science field from an accredited University/College. Responsibilities may include individual, family and group……
19d
Northwest Iowa Community College
Director of Medical Laboratory Sciences Programs
Sheldon, IA
$27.00 Per Hour (Employer provided)
Easy Apply
Coordinate with the Healthcare Clinical Coordinator to interview, hire, and evaluate MLS clinical instructors; arrange contracts for use of clinical facilities;……
30d+
Wellpath
2.8
Medical Director - Days - $24K Bonus
La Belle, PA
$284K - $315K (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+
Newport Healthcare
2.5
Medical Director Psychiatrist
Saint Cloud, MN
$350K - $425K (Employer provided)
Easy Apply
This role encompasses clinical & leadership responsibilities. Join our dynamic team at Newport Healthcare, where you’ll play a vital role in providing……
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……
27d
Wellpath
2.8
Medical Director - Days - $24K Bonus
Marienville, PA
$297K - $330K (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+
The GFS Group
3.0
Food Service Director/Project Manager (FSD/PM)
United States
Easy Apply
Associate’s degree or higher in food service management, Hospitality Management, Business Administration, or a related field from an accredited institution or……
30d+
Providence at Home with Compassus
2.7
Hospice Medical Director/Associate Medical Director
Seattle, WA
$210K - $230K (Employer provided)
Easy Apply
An active and unencumbered Medical Doctor (MD) or Doctor of Osteopathic Medicine (DO) license within the state of employment.…
14d
Big Stone Therapies
4.8
Clinic Manager - Breckenridge
Breckenridge, MN
$19.90 - $30.50 Per Hour (Employer provided)
Easy Apply
They must have, or be eligible for, licensing in Minnesota. This unique dual-role position combines clinical practice with operational leadership, making it……
30d+
Sumner College
4.3
Clinical Instructor (Part-time)
Bend, OR
Easy Apply
Conduct instruction at clinical partner sites in Portland and the surrounding areas, working with groups of up to 8 students. This is a part time position.…
30d+
Monogram Health
2.5
Market Physician Executive (MPE) - Float
Georgia
Easy Apply
Active, unrestricted state medical license required in each state within the market. Current state medical license without restrictions to practice and free of……
30d+
Sound Physicians
3.5
Hospitalist Medicine Medical Director | Physician Led Group!
Lufkin, TX
$240K - $408K (Glassdoor est.)
Board-certified/eligible in family or internal medicine. We proudly sponsor H1B visa candidates and provide in-house visa specialists, licensing, and……
10d
Newlife Discovery Project
2.9
Clinical Director: Community Support & ECM
Redding, CA
$150K - $170K (Employer provided)
Easy Apply
*Licensure:* Active, unrestricted clinical license in California (*LCSW, LMFT, LPCC, or RN*). *Agility: *Ability to move to navigate the "start-up" nature of……
30d+
Monogram Health
2.5
Market Physician Executive (MPE) - Float
Savannah, GA
$158K - $295K (Glassdoor est.)
Easy Apply
Active, unrestricted state medical license required in each state within the market. Current state medical license without restrictions to practice and free of……
30d+
The Crossing Recovery
Clinical Director - Substance Use Disorder (IOP)
Costa Mesa, CA
$136K (Employer provided)
Easy Apply
Active California license required (LMFT, LCSW, LPCC, PsyD, or PhD). High-quality patient care, regulatory compliance, staff supervision, and the implementation……
30d+
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……
18d
Monogram Health
2.5
Market Physician Executive (MPE)
Atlanta, GA
$200K - $374K (Glassdoor est.)
Easy Apply
Active, unrestricted state medical license required in each state within the market. Current state medical license without restrictions to practice and free of……
30d+
The Partners Care
Physician/Medical Director - Skilled Nursing Facility
Newton, MA
$275K - $325K (Employer provided)
Easy Apply
MD or DO with an active and unrestricted medical license in Massachusetts. The ideal candidate is a board-certified or board-eligible physician with experience……
26d
Monogram Health
2.5
Market Physician Executive (MPE) - Savannah, GA
Savannah, GA
$132K - $247K (Glassdoor est.)
Easy Apply
Active, unrestricted state medical license required in each state within the market. Current state medical license without restrictions to practice and free of……
30d+

Ultragenyx

3.4

Executive Director, CMC QA

South San Francisco, 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

South San Francisco, 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

South San Francisco, CA

$294K - $363K (Employer provided)

Ultragenyx

3.4

Executive Director, CMC QA

South San Francisco, 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

South San Francisco, CA

Working here doesn’t have to be a secret

3.4

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

635,946 DIRECTOR, CLINICAL PROGRAMS 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