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.…
13d
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.…
13d
Ultragenyx
3.4
Senior Manager, CMC QA
South San Francisco, CA
$175K - $216K (Employer provided)
Bachelor's degree in a science or related technical field with no less than 7 years relevant industry experience.…
5d
GRX Holdings, LLC dba Medicap Pharmacy
Pharmacy Manager
Greenfield, IA
Maintain state pharmacy license(s). Exercises broad judgment in professional field requiring extensive subject matter knowledge and expertise, while keeping……
30d+
Immanuel Living
3.8
LPN / RN Resource Nurse
Kalispell, MT
$29.00 - $40.00 Per Hour (Employer provided)
Easy Apply
Assist in dining rooms with meals, passing trays/feeding residents/guests. Implement resident/guest plan of care or assist other licensed personnel in……
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……
30d
Hy-Vee HealthMarket
Pharmacist
Zumbrota, MN
$65.00 - $69.00 Per Hour (Employer provided)
Easy Apply
Must be able to handle multiple tasks (filling scripts, answering telephone, waiting on customers, etc.) every day. College degree and licensure in pharmacy.…
30d+
Hy-Vee HealthMarket
Pharmacist
Stewartville, MN
$65.00 - $69.00 Per Hour (Employer provided)
Easy Apply
Must be able to handle multiple tasks (filling scripts, answering telephone, waiting on customers, etc.) every day. College degree and licensure in pharmacy.…
30d+
LINX
3.6
Structured Cabling Project Manager - Commercial Construction
Salt Lake City, UT
$85K - $100K (Employer provided)
Easy Apply
Demonstrated experience interacting regularly with client-side stakeholders including IT directors, facilities managers, and general contractors and electrical……
7d
IT Inspirations
3.1
Memory Care Life Enrichment Manager
Pahrump, NV
$15.00 Per Hour (Employer provided)
Easy Apply
Must have a valid driver’s license and transportation means for work related projects. Files original in the resident’s chart and keeps a copy in a secure area……
26d
Madison Memorial Hospital
3.8
Acute & Critical Care - QTL RN - (FT)
Rexburg, ID
$28.78 Per Hour (Employer provided)
Current unencumbered Idaho or Compact Agreement State RN license. Life management services (child and senior care, moving, pets, home repair, disaster support,……
15d
iLocatum Staffing
3.0
Tax Partner - Public Accounting
Columbus, OH
$175K - $250K (Employer provided)
Easy Apply
Active CPA license or Juris Doctor (JD) degree. You will maintain and deepen existing client relationships through regular outreach, including scheduled calls……
30d+
Voith
3.7
Sr. Tax Analyst
Appleton, WI
$60K - $82K (Glassdoor est.)
Easy Apply
Assist in the preparation of the US federal, state, and local income tax returns, including supporting workpapers and disclosures. Voith US Inc. is hiring:…
30d+
The Formation Project
Attorney (2 Year Legal Fellow)
North Charleston, SC
$58K - $80K (Employer provided)
Easy Apply
Train and provide ongoing guidance to victim advocates and case managers responsible for assisting clients with protective order matters.…
30d+
LINX
3.6
Low Voltage Project Manager - Commercial Construction - SLC
Salt Lake City, UT
$85K - $100K (Employer provided)
Easy Apply
Demonstrated experience interacting regularly with client-side stakeholders including IT directors, facilities managers, and general contractors and electrical……
7d
WIELAND
Traveling Construction Project Manager
Lansing, MI
$80K - $105K (Employer provided)
Easy Apply
Ability to understand and use technology in the field. Actively leads project team with collaboration and inclusion and everyday actions and decisions.…
12d
Trustwell Living
3.4
Director of Nursing
Clyde, OH
$75K - $102K (Glassdoor est.)
Easy Apply
A valid Registered Nurse (RN) license; Compact license or ability to obtain is encouraged. Have a current driver’s license. An unencumbered license is required.…
14d
Eden Senior Care
4.4
Director of Nursing
Pine Island, MN
$105K (Employer provided)
Easy Apply
Valid RN license and CPR certification. Excellent ability to lead and develop personnel. Direct, oversee and evaluate all nursing personnel (registered nurses,……
30d+
Avamere Rehabilitation of Junction City
Resident Care Manager - RN - Avamere Junction City
Junction City, OR
Easy Apply
Current, unencumbered, active license to practice as an RN in this state. Must have an active CPR/BLS certification. Low individual and family deductible.…
7d
Global Water
3.3
Senior Civil Engineer
Maricopa, AZ
$96K - $144K (Glassdoor est.)
Easy Apply
Licenses: Must have a valid Arizona driver’s license. Ability to interpret, understand, and apply engineering standards and procedures, applicable federal and……
30d
Heritage Communities
3.8
Director of Healthcare (RN or LPN)
Grand Island, NE
$58K - $80K (Glassdoor est.)
Easy Apply
Valid driver’s license and acceptable driving record. Must hold active state-required nursing licensure (RN or LPN) and an acceptable record.…
7d
Helping Hands Family
2.8
BCBA Clinical Supervisor - Pittsburgh/Bloomfield - Sign on bonus!!
Pittsburgh, PA
$88K - $95K (Employer provided)
Easy Apply
Active state license where applicable. Ensure compliance with ethical standards as defined by the BACB and relevant state licensure boards.…
30d+
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……
15d
Shapiro & Duncan
4.1
Foreman - HVAC
Rockville, MD
$32.00 - $55.00 Per Hour (Employer provided)
Easy Apply
Valid Driver’s license in good standing (to drive company vehicle). We specialize in full-service mechanical solutions which include engineering, coordination,……
30d+
Child Advocacy Center for the 23rd Judicial District
Mental Health Therapist
Dover, TN
$55K - $63K (Employer provided)
Easy Apply
Clinical license preferred but proof of significant progress towards obtaining license will be considered. License or temp license to practice therapy?…
2d
Fresno PACE For Seniors
2.5
Rehab Manager-OT/PT
Bakersfield, CA
$130K - $140K (Employer provided)
A valid Certified Occupational Therapist Assistant (COTA) or Physical Therapy Assistant (PTA) license in the state of California is required.…
30d+
Catskill Animal Sanctuary
3.4
Shelter Director
Saugerties, NY
$70K - $85K (Employer provided)
Easy Apply
Valid driver’s license and reliable transportation. Field is a plus; direct animal care experience will be considered equivalent to.…
30d+
CODA
2.6
Medical Director (Addiction Medicine) Beaverton Recovery Center
Beaverton, OR
$300K - $325K (Employer provided)
Easy Apply
Board Certification in Addiction Medicine or equivalent advanced certification. MD, DO, or Nurse Practitioner (NP) licensed in Oregon.…
23d
Parameter
Territory Sales Manager-Battery Monitoring Solutions
Fort Collins, CO
$100K - $125K (Employer provided)
Easy Apply
Preferred: recent experience at a competing battery monitoring or critical power vendor; data center sales exposure; familiarity with NERC/CIP; working……
30d+
Petaluma Health Center
3.9
Licensed Marriage and Family Therapist
Rohnert Park, CA
$102K - $135K (Employer provided)
Easy Apply
Maintain professional license, credentials, and relevant training. Consistently uses screening tools to assess mood, risk, and progress in treatment.…
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

46,118 Senior Manager/Director 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