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.…
18d
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.…
18d
Ultragenyx
3.4
Manager, QA Product Disposition
Bedford, MA
$132K - $163K (Employer provided)
Lead and support disposition-related quality activities across internal and external manufacturing sites, ensuring continuity through effective backup coverage,……
11d
Great Plains Health
3.3
Director of Case Management
North Platte, NE
Must possess a current, valid RN license in state of practice, temporary RN license in state of practice, or compact RN licensure for current state of practice.…
30d+
Artemis Practice Services Georgia LLC
Vice President, Operations
Atlanta, GA
Easy Apply
Master’s level degree in Business, Healthcare Administration, other related field. Embed best practices into EMR workflows where possible and develop video-……
21d
Novolex
2.9
Operations Manager
Yakima, WA
$125K - $170K (Employer provided)
The Operations Manager oversees production schedule attainment, quality control and product trials while driving continuous improvement initiatives to optimize……
30d+
Boddie-Noell
2.9
Hardee's Manager - Luray
Luray, VA
$36K - $64K (Glassdoor est.)
Job FunctionsInterview and hire qualified staff to operate the restaurant based on company standards and in compliance with state and federal regulations.…
30d+
Thermo Systems
4.1
Senior Engineering Team Lead
Nebraska
$140K - $150K (Employer provided)
Easy Apply
Maintain a valid driver's license. Actively drive the recruiting, interviewing, and onboarding of engineers (from entry-level to senior), evaluating candidates……
30d+
Thermo Systems
4.1
Senior Engineering Team Lead
Georgia
$140K - $150K (Employer provided)
Easy Apply
Maintain a valid driver's license. Actively drive the recruiting, interviewing, and onboarding of engineers (from entry-level to senior), evaluating candidates……
30d+
Thermo Systems
4.1
Senior Engineering Team Lead
Alabama
$140K - $150K (Employer provided)
Easy Apply
Maintain a valid driver's license. Actively drive the recruiting, interviewing, and onboarding of engineers (from entry-level to senior), evaluating candidates……
30d+
St. John's United
3.4
Director of Accounting and Controller
Billings, MT
$85K - $127K (Glassdoor est.)
Easy Apply
Assist with the design and implementation of accounting practices and internal controls that satisfy audit requirements. Provide immediate service-listen & act.…
5d
Versant Media
3.9
Senior Manager - DTC Partner Operations, MS NOW
New York, NY
$135K - $150K (Employer provided)
Easy Apply
We include a good faith pay range for each position to comply with applicable state and local pay transparency laws and to promote equity across our……
30d+
Forvis Mazars, LLP
3.4
Senior Manager, Healthcare Performance Improvement – Physician Operations
Greenville, NC
$91K - $135K (Glassdoor est.)
Easy Apply
Exposure to provider compensation plans and strategies, including design, evaluation, or implementation. Utilize advanced analytics and visualization tools to……
30d+
ServiceNow
4.0
Senior Manager, Customer Engagement Strategy & Operations - Moveworks from ServiceNow
Mountain View, CA
$196K - $344K (Employer provided)
Easy Apply
Best Places to Work
8 to 10+ years of experience spanning product, sales, strategy, or similar functions; background in solution engineering, product strategy, or management……
30d+
Kao Corporation
3.8
Health, Safety, & Environmental Engineer
Cincinnati, OH
$80K - $105K (Employer provided)
Develop & maintain a high level of professional competence in the health- Safety field. Understand, administer, facilitate, and enforce OSHA, FDA, EPA, MSD, and……
30d+
Stanly County Agri-Civic Center
5.0
Store Manager
Hoxie, KS
$42K - $60K (Glassdoor est.)
Easy Apply
Valid driver's license and clean driving record. Knowledge of large ag equipment or construction equipment is preferred. Must possess basic computer skills.…
30d+
Vuori
3.8
Sr. Talent Program Manager
Carlsbad, CA
$118K - $151K (Employer provided)
Easy Apply
You’ll own building and scaling Vuori’s Talent Practices, shaping how leaders and People & Culture Business Partners across Vuori assess, develop, and plan for……
30d+
Coastline Mortgage
Senior Mortgage Processor → Operations & Growth Leadership
Pasadena, MD
$70K - $80K (Employer provided)
Easy Apply
Pasadena, MD | Full-Time | Primarily In-Office*. $70,000–$80,000 Base Salary + Leadership Growth Bonus Program*. Six-Figure Long-Term Compensation Opportunity*.…
30d+
ProAmpac
2.9
Site Controller (Manufacturing)
Neenah, WI
$80K - $116K (Glassdoor est.)
Easy Apply
Assist the plant manager in managing inventory working capital and driving continuous improvements in this area.…
30d+
Bunnell-Lammons Engineering
3.5
Department Manager | Environmental
Laurens, SC
$42K - $64K (Glassdoor est.)
Easy Apply
Advanced understanding of federal and state environmental regulations, including a strong working knowledge of federal UST regulations and direct experience……
27d
Jamison Professional Services
3.5
Sr. Manager/Vice President - DC/VA/MD
United States
Easy Apply
The Senior Management level professional will provide strategic leadership, organizational stability, and management oversight during a period of transformation……
30d+
Critical Process Systems
3.8
Production/Manufacturing Manager - Vermont
Colchester, VT
$84K - $121K (Glassdoor est.)
Easy Apply
This role carries direct P&L ownership (approximately $ 50 Million) and is accountable for translating strategy into execution by driving daily operations,……
30d+
Bunnell-Lammons Engineering
3.5
Department Manager | Environmental
Inman, SC
$43K - $63K (Glassdoor est.)
Easy Apply
Advanced understanding of federal and state environmental regulations, including a strong working knowledge of federal UST regulations and direct experience……
27d
CORT
3.3
Senior Tenting Project Manager
Everett, WA
$65K - $85K (Employer provided)
Easy Apply
Valid driver’s license, safe driving record, and reliable transportation for travel between job sites/appointments.…
11d
Essential HealthCare Solutions
2.4
Senior Emergency Management Specialist / Planner
Reston, VA
$125K (Employer provided)
Easy Apply
The role combines reach-back planning work from our New Braunfels office with periodic deployment to JFOs, RFOs, and state emergency operations centers in……
30d+
Bunnell-Lammons Engineering
3.5
Department Manager | Environmental
Greenville, SC
$47K - $69K (Glassdoor est.)
Easy Apply
Advanced understanding of federal and state environmental regulations, including a strong working knowledge of federal UST regulations and direct experience……
27d
Essential HealthCare Solutions
2.4
Federal Contracting Financial Manager
Nashville, TN
$71K - $105K (Glassdoor est.)
Easy Apply
One (1) year of experience in the accounting, finance, billing, or accounts receivable field — demonstrated through progressive responsibility in roles such as……
30d+
Pope’s Place
5.0
Rehabilitation Manager (Physical Therapy)
Centralia, WA
$103K - $143K (Employer provided)
Easy Apply
The Rehabilitation Manager is responsible for ensuring safe high-quality rehabilitation services for residents in accordance with current federal, state, and……
27d
FindTalent
Operations Vice President – Extra High Voltage
Fort Worth, TX
$200K - $250K (Employer provided)
Easy Apply
The ideal candidate will have deep technical knowledge of extra high voltage transmission lines, proven leadership in field operations, and experience driving……
30d+
Vytwo
Senior Manager - Technology Strategy and Operations
Dallas, TX
Easy Apply
Bachelor’s degree in Business, Information Technology, Engineering, or a related field. Support organizational effectiveness initiatives, including AI adoption……
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

126,095 Sr.operations 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