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.…
11d
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.…
11d
Beacon Modular
Senior Structural Engineer (Manufacturing/Modular Construction)
Coraopolis, PA
Easy Apply
The Senior Structural Engineer serves as a senior engineering resource responsible for structural design, analysis, and detailing within a modular construction……
18d
MBK Senior Living
3.6
Director of Health Services (RN)
Klamath Falls, OR
$100K - $120K (Employer provided)
Easy Apply
Valid class of driver’s license required by state for vehicle/van(s) capacity and valid insurance. Must have a valid driver’s license for the state hired in and……
20d
AuST Manufacturing
3.9
Director of Technical Operations
West Valley City, UT
$96K - $147K (Glassdoor est.)
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+
Steward Machine
3.4
Senior Estimator
Birmingham, AL
$125K - $132K (Employer provided)
Easy Apply
Bachelor’s degree in engineering, construction management, or a related field preferred; equivalent industry experience will be considered.…
11d
GEA Group
3.7
Senior Process Automation Engineer
Hudson, WI
Incorporate customer specifications and technical requirements into electrical system designs. Collaborate with electrical designers on the design of control……
30d+
Marnie Custom Homes
Custom Builder Design Manager
Bethany Beach, DE
$75K - $115K (Employer provided)
Easy Apply
Resolve field conflicts before they impact construction. Analyze architectural plans, interior elevations, specifications, engineering drawings, and design……
4d
Wiesner Products Inc.
Associate Technical Designer - Men's & Ladies' Active, Lounge, Underwear
United States
$60K - $65K (Employer provided)
Easy Apply
1-2+ minimum years of experience in a technical design or patternmaking role (1 year of an internship w/ a Technical Design or Patternmaking team can be……
5d
Geisinger
3.3
Sonographer, Echocardiography Lead
Danville, PA
Sonographers prepare, administer and document activities related to ultrasound enhancing agents in accordance with federal and state laws, regulations, or……
30d+
Valicor
3.1
Compliance and Sr Approvals Specialist
Monroe, OH
$45K - $65K (Glassdoor est.)
Easy Apply
In this role, you will protect our operations by minimizing compliance risks, ensuring 100% alignment with federal, state, and local environmental regulations,……
11d
Allegiance Gold
4.1
Salesforce Administrator – Five9 & Revenue Operations
Calabasas, CA
$150K (Employer provided)
Easy Apply
Build priority-based workflows for fresh leads, warm leads, callbacks, nurture leads and aged leads. Ensure call outcomes create the appropriate task, status,……
4d
eResources
3.9
Director of Accounts - Digital/Agency Services
Louisville, KY
$100K (Employer provided)
Easy Apply
*Prospecting & business development support*: Maintains a clear understanding of Tectonic's ideal client profile and core service lines; mines inbound leads for……
11d
Lemartec PR
Project Manager - Mechanical Engineer – WWTP
Mayaguez, PR
Oversees the Environmental, Health & Safety program for both the office and field work environments, including contractors and subcontractors.…
3d
ArborPro
3.2
Tree Inventory Inspector / Arborist
Baltimore, MD
$21.00 - $40.00 Per Hour (Employer provided)
Easy Apply
Do you have a valid and current drivers license with an insurable drive record. Progression within this program is based on verified experience, proven field……
30d+
ERC
3.4
SENIOR CNC LATHE MACHINIST
Compton, CA
$25.00 - $35.00 Per Hour (Employer provided)
Easy Apply
A master-level CNC machinist who combines technical expertise, leadership, and a continuous improvement mindset to produce high-precision components while……
30d+
Blue Origin
3.2
Engines Manufacturing Engineer- (All Levels/All Shifts)
Huntsville, AL
Understanding of engineering fundamentals for mechanical design and manufacturing including working knowledge of GD&T. Open to work extended hours if required.…
30d+
Navy Federal Credit Union
3.6
Senior Application Engineer - Oracle ERP-PVM & Ivalua VenDoor
Vienna, VA
$131K - $180K (Employer provided)
Strong written and verbal communication skills for explaining complex technical concepts to both technical and non‑technical stakeholders.…
30d+
Murphy Vogel Askew Reilly
3.0
Senior Associate
Alexandria, VA
$100K (Employer provided)
Easy Apply
Join and observe weekly and other scheduled calls/meetings. Help ensure Partners are prepared with the latest media planning, competitives, spot trackers and……
30d+
Orion Solutions
4.2
Amphibious Ship Diesel Main Propulsion Lead
San Diego, CA
$90K - $130K (Employer provided)
Easy Apply
Understand and provide guidance on shipboard technical data such as: Technical manuals, EOSS, safety procedures, approved maintenance procedure, technical……
3d
Core Impact Inc.
Senior Graphic Designer Contract
Elk Grove, CA
$2,000 (Employer provided)
Easy Apply
Strong understanding of typography design for media, layout design, color management, and print production processes.…
5d
Coral Springs Animal Hospital
2.8
Veterinary Hospital Administrator
Coral Springs, FL
$51K - $81K (Glassdoor est.)
Easy Apply
Build and develop a strong leadership bench (supervisors, managers, leads). This role is best suited for a leader who operates with a business-owner mindset—……
6d
E.S. Wagner
4.3
Senior Project Manager - Bridge / Structures Division
Oregon, OH
$51K - $89K (Glassdoor est.)
Easy Apply
Minimum of 3 years of direct field and supervision experience. Wagner teams to create, own and maintain schedules, budgets, and contracts during the project……
30d+
Autonodyne
2.7
Unity Full Stack Developer
Boston, MA
$90K - $130K (Employer provided)
Easy Apply
Bachelor's degree in computer science/ programming or related field. They have experience working on fast paced software development teams as an individual……
30d+
Etactics
3.4
SaaS Enterprise Sales Rep - Risk & Compliance
Hudson, OH
$60K (Employer provided)
Easy Apply
Bachelor’s degree or global equivalent in an IT, business or sales related field. Collaborate with Marketing department to develop and execute marketing plans,……
30d+
Cypress Assisted Living
ALF Director of Nursing - RN
Anacortes, WA
$95K - $120K (Employer provided)
Easy Apply
_(Compact/multi‑state license accepted if applicable)_. Active Washington State Registered Nurse (RN) license. Assisted Living clinical experience required.…
30d+
Alliance Technical Group
3.1
Senior Environmental Compliance Specialist
Houston, TX
$90K - $115K (Employer provided)
Easy Apply
This position involves a combination of office-based technical work and field activities, typically approximately 70% office and 30% field or travel, depending……
30d+
WELLS
3.9
SENIOR CAD TECHNICIAN
Grand Forks, ND
$28.00 - $43.00 Per Hour (Employer provided)
Easy Apply
Must be able to stand, walk, and navigate active plant and field environments as needed. Occasional visits to active plant and field locations are required……
30d+
Sagemcom
3.5
Senior Hardware Project Manager
Richardson, TX
$130K - $145K (Employer provided)
Easy Apply
\* Analyze field issues and customer feedback; drive root-cause analysis and corrective actions. \* Collaborate closely with mechanical engineering to optimize……
3d
Jacobs
4.0
Unified Communications Engineer - Senior
Warrenton, VA
$155K - $175K (Employer provided)
Easy Apply
Best Places to Work
Proven hands-on technical experience conducting troubleshooting to solve installation and break/fix issues associated with Voice and/or Video over IP products……
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

18,056 LEAD / Senior Profile 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