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.…
17d
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.…
17d
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+
Care At Home
4.0
Home Health RN, Case Manager, Eligible for Sign on Bonus!
Newburyport, MA
$84K - $107K (Employer provided)
Promptly triages patient visits, messages, and phone calls according to priority and urgency. Tuition reimbursement and continuing education support - Access to……
26d
GSG Consultants
3.4
Senior Water Resources Engineer
Schaumburg, IL
$110K - $130K (Employer provided)
Easy Apply
Utilize engineering software and industry-standard tools to perform analysis, design, and document preparation. Certified Floodplain Manager (CFM) preferred.…
9d
Lincoln Street
Registered Nurse
Springfield, VT
$90K (Employer provided)
Easy Apply
Maintain nursing license in the State of Vermont. Train, monitor and delegate staff and contractors in medication administration practice.…
30d+
LINX
3.8
Structured Cabling Project Manager - Commercial Construction
Salt Lake City, UT
$85K - $100K (Employer provided)
Easy Apply
Lead a layered field team of Superintendents, Foremen, Lead Technicians, and Technicians — up to 50 direct field staff plus up to 50 subcontractors across……
11d
TriStar Health
3.4
Cath Lab Clinical Nurse Coordinator
Hendersonville, TN
$76K - $96K (Glassdoor est.)
Easy Apply
Education support through tuition assistance, student loan assistance, certification support, dependent scholarships and a partnership with Galen College of……
30d+
Jordan Valley Community Health Center
2.9
PACE Medical Director, Jordan Valley Senior Care
Springfield, MO
$40K - $72K (Glassdoor est.)
Easy Apply
Qualified Candidates MUST be a M.D. or DO with current state of license. Education: M.D. or DO with current state of license. Provides oversight of the QI Plan.…
30d+
CVS Health
3.2
Pharmacist in Charge - Long Term Care - Full Time
Alexandria, LA
$51.06 - $81.13 Per Hour (Employer provided)
Easy Apply
Must be a licensed pharmacist in the state of Louisiana, must be active & in good standing. Maintain record of all required pharmacist licensure & technician……
4d
UT Southwestern Medical Center
3.9
Senior Counsel, Medical Risk Management
Dallas, TX
$98K - $148K (Glassdoor est.)
Experienced Senior Counsel working under minimal supervision to lead a team of nurse risk managers within the Office of Legal Affairs responsible for handling a……
30d+
Ethos Veterinary Health
3.2
Nurse Manager, ECC, Inpatient & Radiology
Red Bank, NJ
$90K - $100K (Employer provided)
Easy Apply
Engage in interdisciplinary meetings and develop transparent communication protocols. The Nursing Services Manager is the senior-most clinical operations leader……
20d
P2S Inc.
4.3
Senior Commissioning Agent
San Jose, CA
$115K - $150K (Employer provided)
Easy Apply
Valid driver’s license and reliable transportation. Degree in engineering, environmental science, architecture, or related field. Ability to travel up to 30%.…
11d
SIU Medicine
3.0
Sr Construction Project Manager (5012)
Springfield, IL
$7,089 - $7,798 (Employer provided)
The Senior Construction Project Manager is responsible for the scope, budget, and schedule management, contract administration, design and construction,……
30d+
Care At Home
4.0
Home Health Registered Nurse, RN Case Manager
Lowell, MA
$84K - $107K (Employer provided)
Promptly triages patient visits, messages, and phone calls according to priority and urgency. Tuition reimbursement and continuing education support - Access to……
19d
Care At Home
4.0
Home Health Registered Nurse, RN, Lawrence area
Lowell, MA
$84K - $107K (Employer provided)
Promptly triages patient visits, messages, and phone calls according to priority and urgency. Tuition reimbursement and continuing education support - Access to……
26d
Coastline Mortgage
Senior Mortgage Processor → Operations & Growth Leadership
Pasadena, MD
$70K - $80K (Employer provided)
Easy Apply
Have you ever directly supervised or managed mortgage staff? Pasadena, MD | Full-Time | Primarily In-Office*. Six-Figure Long-Term Compensation Opportunity*.…
30d+
People Inc. (NY)
3.3
RN
Niagara Falls, NY
$77K - $83K (Employer provided)
Current NYS license to practice as a Registered Nurse. Participate in introducing nursing students from local nursing programs to the intellectual disability/……
30d+
Particle Measuring Systems
3.8
Lead Opto‑Electronics Engineer
Niwot, CO
$140K - $175K (Employer provided)
Design and develop ultra‑low‑noise, high signal‑to‑noise analog front‑end electronics for optical detection systems. PhD in a relevant technical discipline.…
30d+
Edgewood Healthcare
2.9
Registered Nurse (RN) Manager
Walker, MN
$70K - $75K (Employer provided)
Easy Apply
Current state Registered Nurse (RN) license. Provide clinical oversight of resident care plans. Act as supporting manager and provide training to a team of……
30d
together for youth
3.4
Senior NSD Youth Counselor
Bath, NY
$21.00 - $21.80 Per Hour (Employer provided)
Easy Apply
Must have a valid driver’s license with an acceptable driving history. OR two years of college in a social or human service field (equivalent to 30 credits or……
30d+
Autism Learning Partners
3.0
ABA Sr. Program Manager (Mid-Tier Supervisor)
Chula Vista, CA
$30.50 - $36.50 Per Hour (Employer provided)
Easy Apply
Enrolled in a BCBA program and/or obtaining hours towards certification, preferred. Initial Onboarding Support: 60+ hours of comprehensive training during the……
6d
CenterWell
3.4
Home Health Speech Language Pathologist-PRN
Jacksonville, FL
$54.00 - $76.00 Per Hour (Employer provided)
This role is part of Humana's driver safety program and therefore requires an individual to have a valid state driver's license and are expected to maintain……
24h
CenterWell
3.4
Speech Therapist Home Health PRN
Eastland, TX
$85K - $118K (Employer provided)
This role is part of Humana's driver safety program and therefore requires an individual to have a valid state driver's license and are expected to maintain……
30d+
Kansas Department for Aging and Disability Services
3.1
Litigation Counsel
Shawnee, KS
$82K - $123K (Glassdoor est.)
Easy Apply
In addition, the incumbent assists with agency contracts; may be requested to file Chapter 59 pleadings, and completes any District Court hearings necessary to……
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+
PLSA
Land Development - Civil Senior Project Engineer
Cardiff-by-the-Sea, CA
$105K - $125K (Employer provided)
Easy Apply
Produce construction documents, engineering exhibits, and constraint maps based on field data and techincal research. Civil engineering: 6 years (Required).…
2d
NIFCO America Corp
3.2
IT Application Manager
United States
Easy Apply
Bachelor’s degree in Information Technology, Computer Science, or related field preferred. My role requires that I build strong customer relationships and……
30d+
NVA
2.8
Veterinarian Medical Director
San Antonio, TX
$146K - $272K (Glassdoor est.)
We're looking for a dedicated veterinarian to join our team and continue our legacy of exceptional care in a supportive, state-of-the-art environment.…
30d+
C&L Refrigeration
3.6
Senior HVAC/Refrigeration Technician
Stockton, CA
$35.00 - $60.00 Per Hour (Employer provided)
Is independent in the role, working closely with the Dispatcher daily on your schedule, and completing service calls to different job sites and customers,……
3d

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

56,187 Senior staff program manager 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