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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.…
2d
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.…
2d
Agios Pharmaceuticals
4.1
Manager, GMP Quality Assurance, Clinical, QA
Cambridge, MA
$110K - $165K (Employer provided)
Bachelor’s degree in biology, chemistry, life sciences or a related field. This Quality Assurance professional must possess strong leadership skills in order to……
28d
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Simulstat
4.1
Manager, GMP Quality
United States
Ability to evaluate and troubleshoot complex technical problems independently. Bachelor’s degree in a scientific or technical discipline required.…
17d
Bristol Myers Squibb
3.7
Quality Control Microbiology Laboratory Supervisor
Indianapolis, IN
$108K - $131K (Employer provided)
Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with……
10d
Epic Personnel Partners
2.8
QC Regional Manager
Ruther Glen, VA
$85K - $95K (Employer provided)
Easy Apply
Lead investigations, root-cause analysis, and corrective actions. Responsibilities include supervising QA teams, conducting inspections and audits (scheduled……
2d
FGF Brands
4.1
QA Program Leader
Brownsburg, IN
$77K - $136K (Glassdoor est.)
Postsecondary degree in a relevant field (preferably Biology or Food Science). Assist in follow-up and issue any corrective actions, if necessary, based on……
30d+
Avara Pharmaceutical Technologies
Senior Quality Assurance Associate
Norman, OK
$61K - $66K (Employer provided)
Easy Apply
This position has direct impact on batch processing and release, disposition of materials and components, approval and disposition of minor and major level……
4d
Lonza
3.5
QA Specialist V - QA Inspection Audit Management
Portsmouth, NH
$69K - $103K (Glassdoor est.)
Partner with stakeholders to develop effective corrective and preventive actions. Bachelor’s degree in Life Sciences, Biology, Chemistry, Pharmaceutical……
22d
Vertex Pharmaceuticals
4.1
Manager GMP Quality Operations
Boston, MA
$118K - $178K (Employer provided)
Ability to manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes.…
28d
Vertex Pharmaceuticals
4.1
GMP Operational Quality Manager
Boston, MA
$118K - $178K (Employer provided)
Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement and the analysis/synthesis of a……
30d+
Innophos
3.9
Quality Control Laboratory Manager - Nutrition
North Salt Lake, UT
$50K - $73K (Glassdoor est.)
Easy Apply
Education: Bachelor’s degree in chemistry, Microbiology, or a related scientific field required (master’s degree preferred).…
30d+
Sachs Peanuts
1.4
Plant Manager
Clarkton, NC
$120K - $130K (Employer provided)
Easy Apply
Bachelor’s degree in Industrial Management, Manufacturing, Food Science, or related field preferred; equivalent experience considered.…
30d+
VIVA MFG, LLC.
Facility Sanitation Manager
Tampa, FL
$50K - $60K (Employer provided)
Easy Apply
Ensure the physical plant is maintained in a clean, sanitary condition and in a state of repair sufficient to prevent contamination of components and finished……
4d
Grand River Aseptic Manufacturing
2.8
QA Manager - Butterworth Operations (Weekends Only)
Grand Rapids, MI
$49K - $73K (Glassdoor est.)
Easy Apply
Bachelor’s degree in Life Sciences or a related field and/or a minimum of 8+ years related work experience. Strong technical writing and documentation skills,……
30d+
Premium Waters
3.4
Quality Assurance Technician
Kentland, IN
$22.00 - $24.00 Per Hour (Employer provided)
Easy Apply
While on the production floor in the plant you will be required to follow and help to enforce all GMP regulations in the plant.…
30d+
Trilliant Food & Nutrition
3.5
Production Supervisor
Little Chute, WI
$75K - $85K (Employer provided)
Easy Apply
5+ years plant manufacturing experience in a food industry or related manufacturing facility. Active participation in root cause analysis including preventative……
30d+
HorseShoe Beverage
2.5
QA Supervisor
Neenah, WI
$54K - $71K (Glassdoor est.)
Easy Apply
Experience development, implementation, training, and administration of quality lab processes, GMP, SQF, HACCP, FDA, Kosher or other regulatory or industry……
30d+
Guerbet
3.6
OPEX Manager
Raleigh, NC
$71K - $113K (Glassdoor est.)
The Operational Excellence (OpEx) Manager is responsible for driving continuous improvement initiatives across the Raleigh manufacturing site to enhance……
29d
Rich Products
3.2
QA and Food Safety Manager
Missouri City, TX
$97K - $145K (Employer provided)
BA/BS degree in Business, Supply Chain Operations, Food Science, Engineering or related field. Demonstrated knowledge and application of statistical process……
30d+
Concord Foods
3.1
Sanitation Manager
Brockton, MA
$100K - $120K (Employer provided)
Easy Apply
B.S. in chemical Engineering, Industrial Engineering, Food Science, Microbiology or related field or equivalent related experience.…
25d
Rich Products
3.2
QA Coordinator
Arlington, TN
$64K - $87K (Employer provided)
Associate's degree in Business or related field. In accordance with state law, the rate or range provided is Rich Products Corporation, its subsidiaries and……
3d
PL Developments
3.7
Line Leader (Rogue) - 3rd Shift
Piedmont, SC
You will be a key player in ensuring efficiency, quality, and safety in the manufacturing process. Must upkeep proper PPE requirements within a manufacturing……
30d+
Beauty Manufacturing Solutions Corp
3.8
Compounding Manager - 2nd Shift
Coppell, TX
$48K - $67K (Glassdoor est.)
Easy Apply
Provide a clean, safe, injury-free, working environment while ensuring production quality, on-time product delivery, identifying and employing cost-saving……
11d
PL Developments
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Quality Assurance Inspector - 2nd Shift
United States
Perform the review and verification of the production kits (compounding and packaging) before being used, including sub-assembly components, labels, bottles,……
26d
High Liner Foods
3.6
QA Supervisor 2nd Shift
Newport News, VA
$45K - $63K (Glassdoor est.)
Post‑secondary education in Food Science, Biology, Chemistry, or related field preferred. The incumbent also provides technical QA and food safety support to……
30d+
U Baron Group
2.9
Assistant Sanitation Manager
Louisville, CO
$65K - $80K (Employer provided)
Easy Apply
Assist and maintain the sanitation of facility and all plant equipment for conformity to regulatory and plant standards. All safety protocols must be followed.…
30d+
Kroger
3.1
MFG PLANT SENIOR QUALITY LEADER
Springdale, OH
$70K - $109K (Glassdoor est.)
Bachelors Degree food science or a related field, or equivalent experience. Preventative Control Qualified Individual certification.…
12d
JimmyBar
Quality Assurance Manager
Elk Grove Village, IL
$75K (Employer provided)
Easy Apply
Bachelor’s degree in Food Science, Microbiology, Quality Assurance, or related field preferred. The ideal candidate is both strategic and hands-on — someone……
30d+
Cole's Quality Foods
3.3
Quality Manager
North Liberty, IA
$53K - $85K (Glassdoor est.)
Bachelor’s degree in science or related field preferred. Provide expertise to plant management in current good manufacturing practice (GMPs),.…
10d

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?

1,483 QA Manager- GMP 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