H-1B Visa Quality Management Systems Jobs
Quality Management Systems roles qualify as H-1B visa specialty occupations under the SOC 13-1111 category, requiring at least a bachelor's degree in quality management, industrial engineering, or a related field. Employers across manufacturing, pharmaceuticals, medical devices, and aerospace regularly sponsor H-1B petitions for QMS professionals with ISO 9001, AS9100, or IATF 16949 expertise.
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Get Access To All JobsAt Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
Why Choose Editas?
At Editas Medicine, we’re a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!
Decoding The Role:
The primary focus of this role in the next 12 months is to advance our lead in vivo development candidate, EDIT-401, into the clinic by maintaining, enhancing, and supporting phase-appropriate quality systems and vendor management processes. This role is part of a collaborative QA team, offering opportunities to broaden expertise across multiple Quality disciplines. EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is excited by the potential of this experimental treatment, which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates.
Characterizing Your Impact:
As the Senior Specialist, Quality Systems Management, you will:
- Serve as a subject matter expert for Quality Systems, supporting their effectiveness, compliance, and continuous improvement.
- Support the administration, maintenance, and optimization of the electronic document management system (Veeva QualityDocs), electronic quality management system (Veeva QMS), and learning management system (ComplianceWire).
- Execute and support risk-based supplier management activities, including vendor qualification, performance monitoring, and audit coordination.
- Author, review, and manage GMP documentation, including SOPs, work instructions, and training materials associated with Quality Systems.
- Partner cross-functionally to implement, maintain, improve, monitor, and report on quality and compliance processes.
- Support Quality Operations activities, including record reviews, disposition support, and Quality Event assessments.
- Assist with internal and external audits, inspections, and follow-up activities as needed.
- Identify opportunities for process enhancements and contribute to initiatives that strengthen Quality Systems and compliance performance.
Requirements The Ideal Transcript:
To thrive in this role, you'll need:
- Strong experience administering and/or supporting electronic document management systems, Quality Management Systems, and learning management systems.
- Experience supporting vendor qualification, vendor management, and supplier auditing activities.
- Demonstrated expertise working within cGMP-regulated environments and managing GMP documentation.
- Working knowledge of ICH Q10, FDA regulations, applicable international regulatory standards, and regulatory expectations for clinical-stage biotechnology products, including gene therapy.
- Ability to work independently while collaborating effectively within a cross-functional, team-oriented environment.
- Strong analytical, problem-solving, and critical-thinking skills.
- Excellent organizational and prioritization skills with the ability to manage multiple activities simultaneously.
- Experience supporting biologics, protein, RNA, cell therapy, gene therapy, viral vector, and/or related products.
- Bachelor's degree in a scientific discipline with 5-8 years of Quality Systems, Quality Assurance, or related experience within the biopharmaceutical industry.
Fundamentals That Set You Apart
- Experience supporting Quality Systems within early-phase clinical development organizations.
- Hands-on experience with Veeva Quality applications.
- Auditor training and/or experience supporting supplier or internal audits.
- Experience supporting Quality Operations activities.
- Demonstrated ability to drive process improvements and support inspection readiness initiatives.
Benefits
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
Salary Range:
103,000 - 119,000
Pay Transparency
Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.
Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
Why Choose Editas?
At Editas Medicine, we’re a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!
Decoding The Role:
The primary focus of this role in the next 12 months is to advance our lead in vivo development candidate, EDIT-401, into the clinic by maintaining, enhancing, and supporting phase-appropriate quality systems and vendor management processes. This role is part of a collaborative QA team, offering opportunities to broaden expertise across multiple Quality disciplines. EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is excited by the potential of this experimental treatment, which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates.
Characterizing Your Impact:
As the Senior Specialist, Quality Systems Management, you will:
- Serve as a subject matter expert for Quality Systems, supporting their effectiveness, compliance, and continuous improvement.
- Support the administration, maintenance, and optimization of the electronic document management system (Veeva QualityDocs), electronic quality management system (Veeva QMS), and learning management system (ComplianceWire).
- Execute and support risk-based supplier management activities, including vendor qualification, performance monitoring, and audit coordination.
- Author, review, and manage GMP documentation, including SOPs, work instructions, and training materials associated with Quality Systems.
- Partner cross-functionally to implement, maintain, improve, monitor, and report on quality and compliance processes.
- Support Quality Operations activities, including record reviews, disposition support, and Quality Event assessments.
- Assist with internal and external audits, inspections, and follow-up activities as needed.
- Identify opportunities for process enhancements and contribute to initiatives that strengthen Quality Systems and compliance performance.
Requirements The Ideal Transcript:
To thrive in this role, you'll need:
- Strong experience administering and/or supporting electronic document management systems, Quality Management Systems, and learning management systems.
- Experience supporting vendor qualification, vendor management, and supplier auditing activities.
- Demonstrated expertise working within cGMP-regulated environments and managing GMP documentation.
- Working knowledge of ICH Q10, FDA regulations, applicable international regulatory standards, and regulatory expectations for clinical-stage biotechnology products, including gene therapy.
- Ability to work independently while collaborating effectively within a cross-functional, team-oriented environment.
- Strong analytical, problem-solving, and critical-thinking skills.
- Excellent organizational and prioritization skills with the ability to manage multiple activities simultaneously.
- Experience supporting biologics, protein, RNA, cell therapy, gene therapy, viral vector, and/or related products.
- Bachelor's degree in a scientific discipline with 5-8 years of Quality Systems, Quality Assurance, or related experience within the biopharmaceutical industry.
Fundamentals That Set You Apart
- Experience supporting Quality Systems within early-phase clinical development organizations.
- Hands-on experience with Veeva Quality applications.
- Auditor training and/or experience supporting supplier or internal audits.
- Experience supporting Quality Operations activities.
- Demonstrated ability to drive process improvements and support inspection readiness initiatives.
Benefits
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
Salary Range:
103,000 - 119,000
Pay Transparency
Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.
Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Quality Management Systems
Align your credentials to SOC codes
QMS roles are filed under multiple SOC codes depending on industry context. Check O*NET to confirm which code matches your specific duties, then ensure your resume and degree documentation reflect that classification before applying.
Target regulated-industry employers first
Pharmaceutical, medical device, and aerospace manufacturers have standing compliance obligations that make QMS hires non-discretionary. These employers file H-1B petitions more consistently than general manufacturing because regulatory audits require dedicated QMS staff year-round.
Verify prevailing wage before negotiating offers
Use the OFLC Wage Search to look up the prevailing wage for your SOC code and work location before an employer submits the LCA. Your offered salary must meet or exceed that figure, and knowing it prevents accepting an offer that USCIS will flag.
Check LCA filing history on Migrate Mate
Search QMS job titles by employer on Migrate Mate to see which companies have active LCA filings for your role type. This surfaces employers with a documented history of H-1B sponsorship in quality and compliance functions, not just those claiming they sponsor.
Clarify specialty occupation during the offer stage
QMS roles sometimes draw USCIS requests for evidence questioning whether the position requires a specific bachelor's degree. Ask your prospective employer to document in the job description that a degree in a directly related field is a minimum requirement, not a preference.
Account for cap timing if you're mid-OPT
If you're on OPT and receive an offer after April 1, your H-1B won't be active until October 1 at the earliest. Confirm your OPT expiration date and discuss a cap-gap bridging plan with the employer before signing, since continuous employment depends on unbroken authorization.
H-1B Visa Quality Management Systems: Frequently Asked Questions
Does a Quality Management Systems role qualify as an H-1B specialty occupation?
Yes, provided the employer's job description requires at least a bachelor's degree in a directly related field such as industrial engineering, quality management, or a relevant technical discipline. The key is specificity in the posting. Roles that accept any bachelor's degree regardless of field are more likely to receive a request for evidence from USCIS challenging specialty occupation status.
Which industries sponsor H-1B visas most often for QMS professionals?
Pharmaceuticals, medical devices, aerospace, and automotive manufacturing are the most active sponsors because their operations require ISO, FDA, or FAA compliance frameworks that mandate dedicated QMS staff. These industries face regulatory consequences for quality failures, so QMS hiring is driven by compliance necessity rather than discretionary budget. You can browse verified employers with LCA filing history for these roles on Migrate Mate.
How does the prevailing wage requirement affect QMS job offers?
Before your employer submits the LCA to DOL, they must certify your offered salary meets the prevailing wage for your SOC code and work location. You can look this up yourself using the OFLC Wage Search. If the offer falls below the applicable wage level, the LCA won't be certified, which blocks the H-1B petition from moving forward.
Can certifications like ISO 9001 Lead Auditor strengthen an H-1B petition for a QMS role?
Certifications alone don't satisfy the specialty occupation requirement, but they do support the employer's case that the role demands specialized expertise. When paired with a directly related bachelor's degree and a detailed job description, credentials like ISO 9001 Lead Auditor or ASQ Certified Quality Engineer help establish that the position goes beyond generalist management work.
What happens to my H-1B status if my employer loses a major contract and eliminates the QMS function?
If your employer terminates your position, you have a 60-day grace period to find a new sponsoring employer, transfer your H-1B through a portability filing, or depart the U.S. The new employer must file an H-1B transfer petition before the grace period ends. Your status doesn't transfer automatically, so starting the job search immediately is critical to maintaining lawful status.