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
POWDR
3.4
Risk & Safety Manager
Bend, OR
$80K (Employer provided)
Provide internal risk assessment in collaboration with local leaders and teams by helping answer questions such as whether an activity is safe, what exposure……
10d
safety manager jobs in Bend, OR Bend, OR jobs POWDR jobs in Bend, OR
POWDR salaries safety manager salaries in Bend, OR
Employee reviews at POWDR POWDR interview experience Working at POWDR
Omnidian
4.4
Global Manager of HSEQ (Health, Safety, Environment, and Quality)
Remote
$100K - $135K (Employer provided)
5+ years of leadership experience in HSEQ, HSSE, or Quality Assurance/Operations within solar, electrical, construction, or highly technical field service……
20d
safety manager jobs in Remote Remote jobs Omnidian jobs in Remote
Omnidian salaries safety manager salaries in Remote
Employee reviews at Omnidian Omnidian interview experience Working at Omnidian
Albertsons Companies
3.2
Safety Manager
Las Vegas, NV
$60K - $89K (Glassdoor est.)
Easy Apply
Identify hazards and analyze risks associated with new and existing facilities and equipment and partner with engineering, management, and employees to develop……
24h
safety manager jobs in Las Vegas, NV Las Vegas, NV jobs Albertsons Companies jobs in Las Vegas, NV
Albertsons Companies salaries safety manager salaries in Las Vegas, NV
Employee reviews at Albertsons Companies Albertsons Companies interview experience Working at Albertsons Companies
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+
Magnum Electric
4.1
Senior Director of Safety
West Fargo, ND
$90K - $160K (Glassdoor est.)
Easy Apply
Provide executive oversight of electrical infrastructure construction safety programs, including contractor safety management and site safety leadership.…
28d
J2 Company
Electrical Project Manager
Jackson, TN
$70K - $120K (Employer provided)
J2 Company, LLC is Full-Service electrical and mechanical contractor with a primary focus on state and government facilities management, New construction as……
5d
Posting on Behalf of another company
Senior Electrical Project Manager - DATA CENTERS
Columbus, OH
$150K - $185K (Employer provided)
Easy Apply
HCS is representing our client, ACE Electric, an established electrical contractor seeking a Senior Project Manager to lead complex electrical construction……
21d
C. R. Meyer
3.9
Project Manager (Electrical)
Oshkosh, WI
$72K - $110K (Glassdoor est.)
Easy Apply
Must have a valid driver’s license, insurable driving history and ability to operate a motor vehicle following all traffic laws and safe, courteous driving……
6d
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……
14d
BryMak & Associates
3.0
QCM/SSHO ( Qualitiy Control Manager and Site Safety Health Officer)
Groton, CT
$90K - $100K (Employer provided)
Easy Apply
Education: Bachelor’s degree in engineering, construction management, occupational safety, facility management, or a related field (or equivalent experience).…
30d+
CITY OF PRATT
Police Chief
Pratt, KS
$45K - $95K (Employer provided)
Easy Apply
: A four-year degree in criminal justice, political science, social services, police or a related field is highly preferred, but a combination of experience and……
30d+
Mill
Commercial Launch & Deployment Manager
San Bruno, CA
$160K - $200K (Employer provided)
Easy Apply
6+ years of program management, field operations, or hardware launch experience, with at least 3 years specifically dedicated to B2B, commercial infrastructure,……
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+
LINX
3.6
Structured Cabling Project Manager - Commercial Construction
Salt Lake City, UT
$85K - $100K (Employer provided)
Easy Apply
Lead a layered field team of Superintendents, Foremen, Lead Technicians, and Technicians — up to 50 direct field staff plus up to 50 subcontractors across……
4d
Integrated Steel, Inc
Structural Engineer
Grand Forks, ND
$100K - $250K (Employer provided)
Easy Apply
Works closely with our production team to help develop improved manufacturing and design processes by studying product requirements; researching, designing,……
4d
Netcom Technologies
2.6
Electronic Security Project Manager
Clarksburg, MD
$90K - $140K (Employer provided)
Easy Apply
Demonstrates expertise in commercial low voltage systems installation field management, design and contracting. O Attend Project Kick-Off Meeting.…
30d+
Integrated Steel, Inc
Structural Engineer
Fargo, ND
$100K - $250K (Employer provided)
Easy Apply
Works closely with our production team to help develop improved manufacturing and design processes by studying product requirements; researching, designing,……
4d
RS Line
2.4
Project Manager – Utility Construction
Columbia, SC
$84K - $164K (Employer provided)
Easy Apply
Experience managing field crews and subcontractors on active utility job sites. Coordinate across field, engineering, and internal teams.…
30d+
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.…
4d
ALUKO Group
4.1
Bilingual (Korean& English) Procurement Manager
Halls, TN
$53K - $92K (Glassdoor est.)
Easy Apply
This position is responsible for managing the purchasing and sourcing activities for a fast-paced manufacturing environment, including raw materials, production……
30d+
Xirgo Technologies
Installation Project Manager
Rolling Meadows, IL
$85K - $95K (Employer provided)
Easy Apply
Minimum 5 years' work experience in technical role support mechanical and electrical system in consumer electronics, GPS tracking devices, cameras/CCTV, and/or……
26d
Terracon
3.8
Geotechnical Department Manager I
Tulsa, OK
Valid driver’s license with acceptable violation history. Certification or licensure in field of expertise. Bachelor’s degree in technical discipline practiced……
30d+
Amberwell Health
3.3
Director of Emergency Care
Hiawatha, KS
$57K - $98K (Glassdoor est.)
Ensures compliance with certification and accreditation standards in accordance with Amberwell policies and procedures. Attends other meetings as necessary.…
28d
Clinical Support Options
3.6
CBHC ESP Clinician, Greenfield
Greenfield, MA
$50K - $63K (Employer provided)
Valid driver's license and reliable transportation. Provide clinical services to residents of the Community Crisis Stabilization (CCS) program including risk……
30d+
Continental Shelf Associates
4.6
Senior Geophysical Lead
Stuart, FL
Valid U.S. driver’s license and ability to obtain and maintain a TWIC card. Advanced degree or equivalent professional experience in geophysics, marine……
30d+
Brightwell Behavioral Health
Quality Improvement and Risk Management Coordinator
Garden City, MI
Easy Apply
Collaborate with multidisciplinary health care teams to reduce and prevent adverse medical outcomes, minimize the risk of injury to patient, staff and visitors,……
30d+
Belger Cartage Service
3.5
Corporate Safety Manager
Kansas City, MO
$70K - $90K (Employer provided)
Easy Apply
Conduct regular multi-state safety audits, jobsite inspections, and field observations to verify compliance and identify improvement opportunities.…
30d+
Corrections Technology Group
Hardline Project Manager – DEC / Detention Equipment
Spokane, WA
$80K - $125K (Employer provided)
Easy Apply
This position works closely with CTG leadership, estimating, engineering, procurement, field leadership, subcontractors, general contractors, owners, and……
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

104,778 Risk/Safety 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