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.…
10d
Overhead Door Corporation
3.6
Manufacturing Engineering Manager
Mount Hope, OH
$115K - $136K (Employer provided)
Easy Apply
This role combines technical and operational leadership — managing process optimization, equipment reliability, and capital execution to deliver year-over-year……
25d
Herzog Contracting
3.5
Mechanical Manager
Miami, FL
Maintain a valid driver’s license and endorsements as required per position. Demonstrate ability and availability to respond immediately to emergency or problem……
30d+
GCC & Associates
Construction Manager - Mechanical Engineer
Columbia, MO
$125K (Employer provided)
Easy Apply
Candidates must be able to work on active construction job sites, including wearing required personal protective equipment (PPE) at all times, lifting and……
9d
Alliance on Aging
Finance Manager
Salinas, CA
$120K - $150K (Employer provided)
Easy Apply
Prepare financial reports for federal, state, county, and local funding agencies. Experience with federal, state, county, and local government funding.…
9d
The Robbins Company
3.6
Sr Project Manager Conveyors
Fayetteville, WV
$100K - $110K (Employer provided)
Easy Apply
Requests, processes and manages quotations for manufactured and commercial components related to the project and is in direct contact with the vendors after……
26d
Piper Aircraft
3.8
Sr Manager, Aircraft Certification & ODA Administrator
Vero Beach, FL
$92K - $131K (Glassdoor est.)
Easy Apply
Requires a Bachelors degree in an engineering or technical discipline (preferably Aeronautical or Aerospace) and minimum of eight (8) years aircraft……
30d+
TreeHouse Foods
2.9
Maintenance Manager
Cambridge, MD
$98K - $146K (Employer provided)
Strong knowledge of electronics, controls, mechanical and electrical components found in food manufacturing machinery as well as proper safety standards for……
30d+
GCC & Associates
Construction Manager - Mechanical Engineer
Topeka, KS
$125K (Employer provided)
Easy Apply
Candidates must be able to work on active construction job sites, including wearing required personal protective equipment (PPE) at all times, lifting and……
9d
Novonesis
4.1
Maintenance Technician II (Weekends)
Madison, WI
$25.00 - $34.00 Per Hour (Employer provided)
Hands-on technical skills such as welding, pipe fitting, machining, fabrication, pump/valve rebuilds, and basic electrical work.…
9d
Iowa Aluminum
1.0
Extrusion Manager
Albia, IA
$52K - $78K (Glassdoor est.)
Easy Apply
The Extrusion Manager leads and mentors the production team, monitors equipment performance, troubleshoots process issues, and collaborates with the die shop to……
9d
Enbridge
3.8
Engineer Specialist, System Planning
Salt Lake City, UT
$98K - $129K (Glassdoor est.)
Provide technical leadership, mentorship, and coaching while driving cross-functional collaboration and continuous improvement initiatives.…
2d
Delval Equipment
4.7
Capital Equipment Sales Engineer (Outside Sales) - Boiler Systems
Alexandria, VA
$70K (Employer provided)
Easy Apply
Valid driver's license with clean driving record. The position requires field-based work with clients, contractors, and consulting engineers while collaborating……
2d
Homestyle Direct
3.2
Revenue Operations Manager
Franklin, TN
$75K - $90K (Employer provided)
Easy Apply
Working proficiency with design and visual asset tools such as Figma, Canva, or Adobe Creative Cloud for marketing collateral, landing page mockups, and sales……
30d+
Schreiber Foods
3.8
Maintenance Team Advisor (Supervisor)
Monett, MO
$54K - $80K (Glassdoor est.)
For positions that require any amount of travel: Valid driver's license, auto insurance (at least state minimum- more might be required), acceptable driving……
30d+
International Code Council
3.9
Laboratory Project Manager – Product & Fire Testing
Bryan, TX
$55K - $70K (Employer provided)
Easy Apply
Industrial/Engineering Experience: Proven professional background managing technical projects within a physical testing laboratory, structural testing,……
4d
BBS BUSINESS VENTURES
Sales Engineer
Salinas, CA
$105K (Employer provided)
Easy Apply
The Sales Engineer is a liaison between operations scheduling and field construction crews, and is responsible for effective field operations, project quality……
23d
Wallis Companies
3.6
Lubes - Area Sales Manager
Winchester, VA
Enhance team accomplishments and competence by answering technical and procedural questions for less experienced team members, teaching improved processes, and/……
20d
Summit Midstream Corporation
3.7
Corrosion Technician Lead
Carlsbad, NM
Easy Apply
Provide support and coordinate corrosion mitigation for gathering (gas and liquids), transmission and storage field assets (pipelines, vessels, storage well……
30d+
Aquabiliti
Manufacturing Engineer
Nashville, TN
$75K - $95K (Employer provided)
Easy Apply
Oversee and work closely with the maintenance team, providing technical guidance, prioritization support, and coordination to ensure timely resolution of……
30d+
TreeHouse Foods
2.9
Maintenance Manager
Tonawanda, NY
$98K - $146K (Employer provided)
Strong knowledge of electronics, controls, mechanical and electrical components found in food manufacturing machinery as well as proper safety standards for……
30d+
Cardinal Automation LLC
Controls Engineer
Oklahoma City, OK
$110K - $140K (Employer provided)
Easy Apply
4-year technical degree in mechanical engineering, electrical engineering, or related field preferred. Bachelor's degree in mechanical engineering, electrical……
30d+
GCC & Associates
Construction Manager - Architect Engineer
Kansas City, MO
$125K (Employer provided)
Easy Apply
Bachelor's degree in Arichitecture or Engineering from an accredited school of higher education and 6-10 years experience in both design and construction……
9d
Edfinancial Holdings LLC
Senior System Admin - Knoxville, TN Office Onsite
Knoxville, TN
Easy Apply
Monitor and enforce license agreements using appropriate tools relative to hardware and software resources. To administer and provide central accountability for……
18d
Hermann Wurst Haus
Junior Business Manager & Executive Liaison (Retail Food & Beverage)
Hermann, MO
$18.00 - $22.50 Per Hour (Employer provided)
Easy Apply
You will be the point person for contacting vendors, tracking incoming orders, resolving delays, and managing invoice reconciliation.…
30d+
Fibreworks Composites
3.5
Lamination Lead
Mooresville, NC
$39K - $50K (Glassdoor est.)
In 2019, we expanded our capabilities with the launch of Composite Factory, an AS9100 / ISO-certified sister company serving the Aerospace, Aero Structures,……
18d
UW Health
3.8
RN Manager Inpatient Operating Room
Madison, WI
$114K - $171K (Employer provided)
Direct, plan, implement and evaluate patient care programs for the perioperative patient population. Prior surgical services experience and/or experience……
30d+
Arnett Environmental
5.0
Senior Utility Engineer Water/Wastewater
Orlando, FL
$130K - $230K (Employer provided)
Easy Apply
Controls technical scope, evaluates and approves or rejects change orders, resolves technical disputes, reviews pay applications, and enforces conformance with……
30d+
Temple University Health System
3.5
Manager, OR Patient Flow-Operating Room- 36HR Night Flex Shift (6:30PM TO 7:00AM)-Temple Univ. Hospital
Philadelphia, PA
Contributes to First Case On-Time initiative by: Assigns staff to OR room preparation during nightshift and ensures OR room readiness for First-Cases.…
30d+
Maytag Aircraft
3.6
Business Development - Capture Manager
Colorado Springs, CO
$84K - $133K (Glassdoor est.)
This position develops and executes capture strategies designed to increase win probability and expand Maytag Aircraft’s capabilities and market presence.…
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

Are you open to new opportunities?

150,827 Operating system 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