Notifications

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
Yum! Brands
3.6
Global People Technology Product & Adoption Leader
Plano, TX
$165K - $194K (Employer provided)
Bachelor's degree in human resources, Information Systems, Business, Computer Science, or related field. Build, develop, and mentor a high-performing global……
8d
Plano, TX jobs Yum! Brands jobs in Plano, TX
Yum! Brands salaries
Employee reviews at Yum! Brands Yum! Brands interview experience Working at Yum! Brands
HireRight
3.2
Proposal Writer
Nashville, TN
$63K - $93K (Glassdoor est.)
Perform necessary research and analysis as needed to answer prospect/client questions including coordinating with internal stakeholders to gather technical and……
5d
MTSI
4.8
SIM Operations Engineer
Edwards AFB, CA
8+ years’ experience in related engineering discipline. Executes data analysis and development of reporting products for customers.…
30d+
Thrivent
3.7
Financial Advisor - Waukesha, WI and Surrounding Areas
Waukesha, WI
Easy Apply
We offer up to 14 weeks of paid training and coaching as you obtain your state insurance licenses (life, health & variable contracts), Series 7 and 66……
30d+
Constellium
4.0
Plate Engineering Lead
Ravenswood, WV
$78K - $118K (Glassdoor est.)
Supervision of APU and 3rd party engineering teams for APU projects and activities. Establishes capital project portfolio, resource, requirements and……
30d+
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
Stafast Products
4.0
Sales Specialist
Pontotoc, MS
Easy Apply
Associate or bachelor’s degree in business, Sales, Marketing, or a related field preferred. Position SummaryThe Sales Specialist is responsible for driving……
15d
Autonodyne
2.7
Senior Unity Full Stack Developer
Boston, MA
$120K - $180K (Employer provided)
Easy Apply
Bachelor's degree in computer science/ programming or related field. Master's degree in computer science/ programming or related field.…
30d+
Eastman
3.3
Mechanical Engineer
Monongahela, PA
$100K - $115K (Employer provided)
Easy Apply
Ability to work in a team environment with other engineers, technicians, field maintenance forces, and contractors. Very service oriented and customer focused.…
21d
ALUKO Group
4.1
Anodizing Manager
Halls, TN
$100K (Employer provided)
Easy Apply
Build and develop a strong production team during plant startup. Bachelor’s degree in Engineering, Manufacturing, Industrial Technology, or related field.…
30d+
Fluid Imaging Technologies
3.4
Quality and Supply Chain Manager
Scarborough, ME
$100K (Employer provided)
Easy Apply
Establish and monitor key quality metrics (e.g., yield, defects, field performance, customer complaints) and lead corrective and preventive actions (CAPA).…
30d+
Rehlko
3.1
Sr Project leader - Engineering Systems
Sheboygan, WI
$88K - $111K (Employer provided)
Lead discovery in ambiguous environments (unknown stakeholders, unclear current state, limited documentation) to quickly establish current-state understanding……
9d
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+
Russell Technical Consulting Services
5.0
Senior Program Analyst
Huntsville, AL
$96K - $130K (Glassdoor est.)
Easy Apply
Bachelor’s degree in technical or business field. Advanced degree in technical or business field. You will work with the science and technology community,……
24h
Linde
3.5
Field Service Technician
Martinsburg, WV
$50K - $67K (Glassdoor est.)
Easy Apply
Lastly coordinate contractors and resources to support plant activities, audits, and administrative requirements while driving efficiency through strategic……
30d+
Linde
3.5
I&E Technician
Claremore, OK
$34K - $49K (Glassdoor est.)
Easy Apply
This person will be expected to work independently as a self-starter and make technical decisions and recommendations in the field.…
30d+
Linde
3.5
Field Service Technician
Ferndale, WA
$80K - $95K (Employer provided)
Easy Apply
Employees in this role will solve field site issues, maintain, and operate the air separation plant, as well as have customer interaction on a variety of……
30d+
Thrivent
3.7
Financial Advisor - Northern Highland Financial Advisors
Stevens Point, WI
$90K - $165K (Employer provided)
Easy Apply
We offer up to 14 weeks of paid training and coaching as you obtain your state insurance licenses (life, health & variable contracts), Series 7 and 66……
30d+
BAE Systems USA
3.7
Senior Principal Systems Engineer II - Systems Architect
Endicott, NY
$136K - $231K (Employer provided)
Bachelor's Degree in related engineering field. Master’s Degree in related engineering field. BAE Systems wants your Systems Engineering talent to perform……
30d+
BAE Systems USA
3.7
FPGA Design Manager / Section Lead
Totowa, NJ
$153K - $261K (Employer provided)
Candidates should also have experience leading design engineers within multi-disciplined engineering teams through all phases of the Hardware and or FPGA/ASIC……
30d+
thyssenkrupp
3.7
Product Development Engineer
Fishers, IN
$80K - $105K (Glassdoor est.)
Co-own design activities on assigned projects, including print dimensions, specifications, and datum definitions. Advanced Engineering Degree is a plus.…
14d
PMC Organometallix
Chemist Research and Development
Lansdale, PA
Easy Apply
Issue Call Reports for customer visits/calls and conferences. Excellent interpersonal skills needed to work with diverse group of chemists, engineers,……
15d
Navaera
3.9
Compliance and Controls Engineer
Scottsdale, AZ
$90K - $126K (Employer provided)
Easy Apply
The successful candidate will work cross-functionally with leadership, application development, data engineering, quality assurance, and delivery operations……
30d+
CFR Engines
2.5
Senior Mechanical Project Engineer
Waukesha, WI
$105K (Employer provided)
Easy Apply
Develop mechanical system design solutions based on engineering principles. Must possess a high level of Mechanical engineering aptitude including a broad……
21d
The Hershey Company
3.5
Staff Engineer R&D Process Technology
Hershey, PA
$86K - $129K (Glassdoor est.)
This role applies process engineering and food science expertise to develop scalable process technologies that support innovation, validation, and……
7d
Linde
3.5
Operations Process Engineer - West Region
Magna, UT
$107K - $156K (Employer provided)
Easy Apply
The engineer will be required to utilize a variety of engineering tools which may include process models, historical operating data, statistical analysis tools,……
30d+
Titomic
4.3
Program Manager
Madison, AL
$70K (Employer provided)
Easy Apply
The Program Manager serves as the primary interface between customers, executive leadership, engineering, manufacturing, supply chain, and operations while……
24h
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+
Linde
3.5
Maintenance Planner/Scheduler
East Chicago, IN
Easy Apply
Develop job steps for work to be performed including – resource requirements (crafts and durations), parts and materials, special tools, technical info/sketches……
30d+

Ultragenyx

3.4

Executive Director, CMC QA

Novato, 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

Novato, 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

Novato, CA

$294K - $363K (Employer provided)

Ultragenyx

3.4

Executive Director, CMC QA

Novato, 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

Novato, CA

Working here doesn’t have to be a secret

3.4

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

62,751 Global product and technology development program 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