Notifications

Are you open to new opportunities?

Upload your resume to increase your chances of getting noticed.

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.…
9d
Ultragenyx
3.4
Sr. Facilities Engineer
Bedford, MA
$158K - $195K (Employer provided)
Exercises independent judgment to determine and recommend appropriate actions on behalf of engineering and represents engineering programs to external……
17d
StandardAero
3.3
Senior Finance Director - San Antonio
San Antonio, TX
$132K - $195K (Glassdoor est.)
Shared service cost control: develop and execute robust cost allocation methodologies across five existing platforms and ensure scalable growth associated with……
12d
The Cigna Group
3.5
Program Management Senior Advisor - Cigna Healthcare - Remote
Remote
$116K - $194K (Employer provided)
This position is responsible for driving awareness, assessment and implementation of new federal and state laws, which includes reviewing impacts of new and……
4d
advisor jobs in Remote Remote jobs The Cigna Group jobs in Remote
The Cigna Group salaries advisor salaries in Remote
Employee reviews at The Cigna Group The Cigna Group interview experience Working at The Cigna Group
Pantheon Data
2.7
Senior Marine Electronics Exterior Communication Engineer
Washington, DC
$90K - $110K (Employer provided)
Easy Apply
Apply knowledge of and experience with engineering principles and techniques, to develop and evaluate moderately complex technical reports related to……
11d
ENFRA
3.6
Pre Commission Agent Senior
Rayville, LA
$32.10 - $42.88 Per Hour (Employer provided)
Operating machinery and/or power tools. Knowledge of more complex system concepts and troubleshooting methodologies. 30 hours of continued education.…
22d
Rapides Regional Medical Center
3.3
RN Shift Supervisor - Ortho Neuro Trauma
Alexandria, LA
Easy Apply
Education support through tuition assistance, student loan assistance, certification support, dependent scholarships and a partnership with Galen College of……
30d+
AuST Manufacturing
3.9
Director of Technical Operations
West Valley City, UT
Easy Apply
You have personally designed and built automated manufacturing equipment — not supervised a vendor who built it, but done the mechanical design, electrical……
30d+
Rapides Regional Medical Center
3.3
RN Supervisor Cardiovascular ICU
Alexandria, LA
$75K - $102K (Glassdoor est.)
Easy Apply
Education assistance (tuition, student loan, certification support, dependent scholarships). Referral services for child, elder and pet care, home and auto……
30d+
Teck Resources Limited
4.0
Senior Engineer, Tailings and Closure
Idaho
$101K - $131K (Employer provided)
Provide rigorous contractor and consultant management, including scope development, budgeting, execution oversight, safety compliance, quality control, and……
11d
Vermont 2-1-1
2.0
Director of Finance and Administration - Hybrid within Vermont
Montpelier, VT
$75K - $82K (Employer provided)
Easy Apply
Ensure timely filing of Form 990 and applicable state tax and compliance documents. Manage financial oversight and compliance for all state contracts and……
3d
Thrivent
3.7
Director of Planning Operations – Voyage Financial Advisors
Stevens Point, WI
$90K - $135K (Employer provided)
Easy Apply
Assist not only in the creation of financial plans but help assist the advisory team by creating straightforward implementation steps for the advisors to help……
24d
Gestra Engineering
3.8
Senior Construction Materials Testing Technician
Milwaukee, WI
$25.00 - $30.00 Per Hour (Employer provided)
Easy Apply
Must possess a valid driver's license and have a good driving record as well willingness to drive to job sites. Education: High school diploma or GED.…
30d+
D-RIVEN Engineered Solutions
4.6
Electrification Engineering Manager
Canton, MI
$111K - $120K (Employer provided)
Easy Apply
15+ years of combined experience in electrical engineering, industrial electrical installation or maintenance, or an equivalent field.…
30d+
Ellis Medicine
3.2
Senior Histotechnician
Schenectady, NY
$24.75 - $36.53 Per Hour (Employer provided)
Easy Apply
Must be able to perform tasks which require hand-eye coordination such as data entry, typing, and using photo copiers. Embed processed tissue in paraffin.…
30d+
Wendler
Senior Safety Manager
Cedar Rapids, IA
$115K - $145K (Employer provided)
Easy Apply
The right individual will bring both field credibility and leadership presence, someone capable of driving accountability, building trust, gaining buy-in from……
30d+
Blue Origin
3.2
Test Engineer - Fluids | New Glenn (Mid to Senior | D and 3rd Shift)
Florida
Minimum of a Bachelor’s degree in mechanical, aerospace, civil engineering or related field. You will develop test methods, operate ground support equipment,……
30d+
AccraFab
2.6
Senior Buyer
Liberty Lake, WA
$24.00 - $30.00 Per Hour (Employer provided)
Easy Apply
A degree in Supply Chain Management, Business, or a related field is preferred but not required. Build, develop, and manage strategic supplier relationships.…
30d+
First Mid Bank & Trust
3.5
Senior Fiduciary Officer
Peoria, IL
$95K - $130K (Employer provided)
Easy Apply
Adequate knowledge of both internal policies and procedures and the respective state and federal laws and regulations governing departmental functions to ensure……
30d+
ESP inc
3.6
Site Manager/Sr. Simulator Technician
United States
$40.00 Per Hour (Employer provided)
Easy Apply
Generates contract field service reports and other reports as needed. Graduate from a two-year resident Electronics Technician course at an accredited technical……
30d+
City of Chesterfield
3.5
Senior Engineering Construction Inspector
Chesterfield, MO
$29.77 Per Hour (Employer provided)
Successful candidate must possess a valid vehicle operator’s license. Associates degree in related field preferred. High school diploma or equivalent required.…
26d
Verus Research
4.1
Information Systems Security Manager (ISSM)/Alternate Facility Security Officer (AFSO)
Albuquerque, NM
$158K (Employer provided)
Easy Apply
Bachelor’s degree in a Cybersecurity or IT related field required. License/Certification: IAM Level III certification – CISSP: required, GSLC or CISM:……
15d
JE Dunn Construction
4.5
Senior Design Manager - Design for Manufacturing
Kansas City, MO
The Senior Design Manager is accountable for the design for manufacturing teams’ performance, financial stewardship, staff development, and continuous……
30d+
Dungan Engineering, P.A.
Certified Bridge Inspector
Columbia, MS
$25K - $55K (Employer provided)
Easy Apply
The certified Bridge Inspector is required to perform field inspections of bridges and related structures, assess their condition and safety, and document……
22d
Material Handling Systems
Senior Crane Technician
Braddock, PA
$25.00 - $35.00 Per Hour (Employer provided)
Easy Apply
Reporting to the Branch Manager, your role requires strong mechanical knowledge and expertise in automotive diagnostics, hydraulics, and electrical systems.…
30d+
Lemonjuice Capital
Maintenance Manager- BC
Ocean City, MD
$70K (Employer provided)
Easy Apply
Installs, maintains, performs preventative maintenance on, and recommends replacement of tools, appliances, and equipment. Work Type: Full-time, year-round.…
18d
Trustwell Living
3.4
Assistant Health Services Director (RN)
Dubuque, IA
$90K - $110K (Employer provided)
Easy Apply
A valid Registered Nurse (RN or LPN) license; a Compact license or the ability to obtain one is encouraged. Have a current driver’s license.…
7d
Illuminus
2.4
Assistant Director of Nursing
Fond du Lac, WI
$83K - $100K (Employer provided)
Easy Apply
Registered Nurse license in the State of Wisconsin. Knowledge and/or experience with state and federal regulations. Coordinate the care planning program.…
2d
Geisinger
3.4
Radiology Technologist Weekender Days
Wilkes-Barre, PA
Reports equipment malfunctions and the need for adjustments or repairs. $20,000 Sign on bonus for eligible applicants! weekender premium 7a-730p Sat/Sun/Mon……
30d+
Geisinger
3.4
Diagnostic Radiology Technologist - Evenings
Wilkes-Barre, PA
Reports equipment malfunctions and the need for adjustments or repairs. $20,000 Sign on bonus for eligible applicants! Maintains related records and notations.…
4d

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

Are you open to new opportunities?

106,998 Senior program control an 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