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, Investigations
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……
24h
Piper Aircraft
3.8
Sr Manager, Aircraft Certification & ODA Administrator
Vero Beach, FL
$92K - $131K (Glassdoor est.)
Easy Apply
Requires a Bachelors degree in an engineering or technical discipline (preferably Aeronautical or Aerospace) and minimum of eight (8) years aircraft……
30d+
Vanderbilt University Medical Center
3.8
CT Tech I Weekend Days I Tullahoma Hospital I $10k sign on
Tullahoma, TN
Best Places to Work
Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with……
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+
Magnum Electric
4.1
Senior Director of Safety
West Fargo, ND
$90K - $160K (Glassdoor est.)
Easy Apply
The Senior Director of Safety is responsible for developing, leading, and continuously improving Magnum Electric’s enterprise-wide safety strategy across……
29d
Well Medical Arts
Master Injector/Medical Director
Seattle, WA
$75.00 - $100.00 Per Hour (Employer provided)
Easy Apply
Active NP or MD license (with appropriate injectable certifications). *Act as Medical Director*: Provide medical oversight, develop and maintain clinical……
26d
FirstEnergy
2.6
Distribution Line Instructor IV - Reading PA
Reading, PA
Evaluate trainee progress through practical assessments, written tests, and field observations; provide constructive feedback and guidance.…
11d
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
Turn Key Health Clinics
3.1
Medical Director
Tulsa, OK
$143K - $265K (Glassdoor est.)
Easy Apply
Active, unrestricted Oklahoma MD or DO license. Active, unrestricted MD or DO license in Oklahoma (required). Provide medical leadership and clinical oversight……
30d+
Curry Health Network
2.7
CT Technologist
Medford, OR
$44.89 - $67.90 Per Hour (Employer provided)
Easy Apply
OBMI State of Oregon Radiography and Computed Tomography license required. Hearing requirements: ability to hear alarms on equipment, patient calls, and……
30d+
Compass Health (CA)
3.3
Registiered Dietitian
Grover Beach, CA
$45.00 - $55.00 Per Hour (Employer provided)
Easy Apply
Compass Health Inc. is seeking a Registered Dietitian to support our skilled nursing facilites by providing nutrition assessments, developing care plans,……
7d
Navarro Regional Hospital
2.4
Nursing Director of Women's Services
Corsicana, TX
$71K - $98K (Glassdoor est.)
Easy Apply
Bachelor's Degree in relevant field required or. Proficiency with Google and Microsoft platforms, healthcare software systems, and data analysis tools.…
30d+
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+
Vitaly Clinical Research
Clinical Research Principal Investigator
Plano, TX
$120K (Employer provided)
Easy Apply
Active MD or DO license in Florida. Provide medical oversight for assigned clinical studies. Our experienced research team manages the day-to-day study……
22d
Coast Ambulatory Surgery Center
Director of Nursing
Templeton, CA
$60.00 - $65.00 Per Hour (Employer provided)
Easy Apply
Oversee the implementation, organization, auditing, and maintenance of surgical charts to ensure accuracy and compliance with Medicare and AAAHC standards.…
30d+
Healthcare Services Group
3.1
Lead Registered Dietitian
Virginia Beach, VA
$75K (Employer provided)
Registered by the Commission on Dietetic Registration of the Academy of Nutrition and Dietetics and licensed in Nutrition/Dietetics as required by the……
7d
Capitol Pain Institute
2.5
ASC Nurse Administrator - Louisville | No Weekends, Evenings, or On Call!!!
Louisville, KY
$115K - $125K (Employer provided)
Easy Apply
Current and valid driver’s license and proof of valid automotive insurance. Work closely with clinical leaders to assess infection risks, develop mitigation……
30d+
Grace Inspired Living
2.9
Director of Nursing
Telford, PA
$74K - $100K (Glassdoor est.)
Know and enforce state and federal regulations. Develop and implement criteria and tools to evaluate the effectiveness of the Nursing Department.…
7d
GKN Aerospace
3.3
Quality Manger - MRB
Cromwell, CT
$105K - $154K (Glassdoor est.)
This includes knowledge of management and planning tools, quality tools, preventive and corrective actions, and how to overcome barriers to quality improvements……
30d+
Vessey & Company
Chief Financial Officer
Holtville, CA
$100K - $200K (Employer provided)
Easy Apply
Utilize predictive analytics and AI-enabled forecasting tools to improve budgeting, cash flow management, crop profitability analysis, inventory management, and……
13d
Annashae Staffing
2.1
Medical Director - Experienced Forensic Psychiatrist
Sparta, IL
$41,600 (Employer provided)
Easy Apply
Valid unrestricted medical license in Illinois or the ability to obtain one quickly (current member of compact licensure process).…
30d+
Raymond James Financial
4.1
Director, Operations | New Accounts
Saint Petersburg, FL
$70K - $122K (Glassdoor est.)
Best Places to Work
Review and evaluate recommendations and requirements and to develop appropriate plans or deliver actions required.…
30d+
Amedisys
3.3
Physician Associate Medical Director
Monroeville, PA
$175.00 Per Hour (Employer provided)
Current and unencumbered license to practice specific to that state assigned to work in. Valid driver's license and reliable transportation and agency required……
25d
Lifecore Biomedical
3.2
Sterility Assurance Engineering Manager
Chaska, MN
$130K - $160K (Employer provided)
Advanced critical thinking, root cause analysis, and technical investigation skills. Demonstrated expertise in risk assessment tools (e.g., FMEA, FTA) and……
30d+
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
Confidential
Vice President of Engineering
Universal City, TX
$130K - $175K (Employer provided)
Easy Apply
Lead and mentor multidisciplinary engineering teams specializing in avionics systems, software development, system design, and integration.…
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+
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……
25d

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

175,342 Associate Director, Regulatory 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