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.…
8d
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.…
8d
Ultragenyx
3.4
Sr. Facilities Engineer
Bedford, MA
$158K - $195K (Employer provided)
Exercises independent judgment to determine and recommend appropriate actions on behalf of engineering and represents engineering programs to external……
17d
Yocha Dehe Wintun Nation
3.2
Communications Manager
Brooks, CA
$96K (Employer provided)
Easy Apply
Must possess a valid drivers’ license and maintain a driving record that is satisfactory to the Tribe’s insurance carrier.…
30d+
Commonwealth of Pennsylvania
3.5
Civil Engineer Manager (General)
Emporium, PA
$84K - $120K (Employer provided)
This position requires possession of a valid driver’s license. This position requires possession of a valid Professional Engineer license issued by the……
12d
Acra Aerospace
2.0
Director of Engineering and CI
Anaheim, CA
$135K - $175K (Employer provided)
Easy Apply
This role is a *hands-on engineering leadership position* responsible for driving manufacturing excellence, leading New Product Introductions, and building a……
30d+
INYA Inc.
Senior Environmental Project Manager (PE/PG)
San Diego, CA
$140K - $190K (Employer provided)
Easy Apply
Valid driver's license and ability to travel to project sites, client meetings, and field locations as needed. Must be authorized to work in the United States.…
22d
Teck Resources Limited
4.0
Senior Engineer, Tailings and Closure
Idaho
$101K - $131K (Employer provided)
Provide geotechnical and geoenvironmental technical leadership for tailings and water-retaining structures, including support for investigations, construction,……
11d
GEA Group
3.7
Senior Manager - Process & Project Engineering - Sanitary PTS
Hudson, WI
$120K - $140K (Employer provided)
Supports Technical Offer Management (TOM) during pre-sale including input and review of engineering hours, provide historical data for costing; as well as……
30d+
Swagelok
3.8
Sales Market Manager - Oil & Gas Industry
Anchorage, AK
$120K (Employer provided)
Easy Apply
*Review and understand technical drawings:* Reads and interprets engineering drawings, schematics, and specifications to support customer applications, validate……
3d
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+
Defense Technical Recruiting, LLC
Senior Cybersecurity Architect PM (Security Clearance Required)
Colorado Springs, CO
$175K - $200K (Employer provided)
Easy Apply
This position serves as a senior technical authority for the DCO-S enterprise, responsible for driving system architecture, technical performance, and……
7d
Patterson & Dewar Engineers
4.3
Smart Grid Engineering Manager
Norcross, GA
$88K - $134K (Glassdoor est.)
Easy Apply
Professional Engineer (P.E.) or EIT certified (passed FE Exam) with the intent to pursue P.E. license. Travel to project sites to gather design information;……
30d+
DaVita
3.2
Clinical Services Manager (MCS)
Indianapolis, IN
Current driver’s license, reliable transportation, and vehicle insurance in the state of residence. Education to commensurate with RN license.…
30d+
PMC Organometallix
Production Manager
Axis, AL
Easy Apply
This person will work very closely with the PMC senior process engineer, manage the other PMC process engineer, and coordinate with embedded multi-plant……
30d+
Cabot Creamery
4.3
Environmental Health & Safety Manager
Cabot, VT
$93K - $103K (Employer provided)
Easy Apply
Bachelor's degree in a related field of of study (e.g., industrial hygiene, occupational health and safety, engineering or technical preferred) with 3-5 years……
23d
Verus Research
4.1
Information Systems Security Manager (ISSM)/Alternate Facility Security Officer (AFSO)
Albuquerque, NM
$158K (Employer provided)
Easy Apply
Bachelor’s degree in a Cybersecurity or IT related field required. License/Certification: IAM Level III certification – CISSP: required, GSLC or CISM:……
15d
Memorial Healthcare (Michigan)
3.7
Registered Dietitian - $10k Sign On Bonus Offered to External Candidates!
Owosso, MI
Must be able to develop and implement nutrition care plans. Responsible for establishing and monitoring all continuous quality improvement issues for areas of……
30d+
Lynn Community Health Center
3.5
RN Manager
Lynn, MA
$80K - $95K (Employer provided)
Easy Apply
Participate in direct and indirect patient care for patients who have HIV, and/or HCV and/or TB or LTBI and/or Sexually Transmitted Infections, and/or Hepatitis……
30d+
SOPREMA Canada
3.6
QHSE Supervisor
La Grange, GA
$80K - $95K (Employer provided)
Easy Apply
Bachelor’s degree in Chemical Engineering, Quality, Environmental Health & Safety, or a related technical field. Develop, implement, and maintain HSE policies.…
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+
Cogentrix
3.9
Operations Manager
Towanda, PA
$165K - $175K (Employer provided)
Easy Apply
Must have a valid driver’s license. Directs the activities of Operating Shifts and other personnel assigned to the Operations Department to ensure that……
22d
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,……
2d
4Front Solutions
2.1
Engineering Manager
Erie, PA
$100K - $139K (Glassdoor est.)
Easy Apply
Prepare processes, drawings, and develop tools for manufacturing processes in order to generate or improve efficient production throughput.…
30d+
Overhead Door Corporation
3.6
Manufacturing Engineering Manager
Mount Hope, OH
$115K - $136K (Employer provided)
Easy Apply
Acts as a technical leader and coach — developing engineering and maintenance talent through hands-on mentorship. Reports to: Plant Manager (Hard Line).…
23d
Flex-N-Gate
3.5
Tooling Manager
Effingham, IL
$135K (Employer provided)
Easy Apply
Works with design to ensure that manufacturing best practices and safety are integrated into design of all new production tools.…
30d+
Catalent Pharma
2.8
Manager - Engineering
Madison, WI
$107K - $152K (Glassdoor est.)
Technical or associate degree in engineering or related scientific field with a minimum of 10+ years related work experience OR. Work Schedule: M-F 8am-5pm.…
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
NAPA Auto Parts
3.4
Engineering & Automation Manager
Manheim, PA
$73K - $114K (Glassdoor est.)
Easy Apply
Lead and develop field engineering and maintenance team as applicable to sustain run-state operations across respective site(s).…
9d
Pediatric Sleep Specialists
1.0
Polysomnographic Technologist/Sleep-Experienced - FT
Loveland, CO
$40.00 - $44.00 Per Hour (Employer provided)
Easy Apply
Current BLS/PALS certification from the American Heart Association. Will serve as a mentor to new employees or current employees as assigned by the manager/……
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?

225,364 Technical programs 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