Quality Manager Jobs in USA with Visa Sponsorship
Quality Manager roles qualify for H-1B visa sponsorship as a specialty occupation requiring a bachelor's degree in engineering, quality science, or a related field. Employers filing a Labor Condition Application must certify prevailing wage compliance before you can apply. No lottery exemption exists, but cap-exempt employers like universities and nonprofit research organizations offer an alternative path. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsLooking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us.
Hybrid: 3-days per week on-site
Employee Value Proposition
At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an opportunity to contribute to Quality Assurance activities in a dynamic, collaborative, and global cross-functional environment.
Position Summary:
The Manager, Quality Assurance Operations – Vendor & Audit Management is responsible for the day-to-day execution and administration of the Quality Assurance vendor and audit management program under the strategic direction of the Director, Quality Assurance Operations. The position manages operational audit activities and associated records within TrackWise Digital (TWD), supporting the audit lifecycle from initiation and scheduling through reporting, CAPA follow-up, and closure. The Manager works with internal stakeholders, auditors, vendors, and Quality colleagues to ensure activities are completed accurately, consistently, and in accordance with applicable procedures and regulatory expectations.
Performance Objectives:
Audit Management
- Coordinate the operational lifecycle of assigned GxP audits, including vendor audits and other Quality audits.
- Schedule audits and coordinate logistics with auditors, vendors, and internal stakeholders.
- Support audit preparation by collecting relevant documentation and ensuring required information is available.
- Maintain audit records and track activities through report issuance, response, CAPA management, follow-up, and closure.
- Monitor commitments and due dates and follow up with responsible stakeholders to support timely completion.
- Escalate significant compliance concerns, overdue activities, and emerging risks to the Director and appropriate Quality leadership.
TrackWise Digital Administration
- Perform day-to-day data entry and record maintenance for vendor and audit management activities in TWD.
- Create and maintain accurate audit and vendor records and supporting documentation.
- Track assigned actions, CAPAs, due dates, status changes, and closure activities in TWD.
- Perform routine data-quality checks to support the completeness, accuracy, and consistency of records.
- Support generation of audit and vendor management data for periodic reporting, metrics, trending, and management review.
- Identify data or workflow issues and escalate them to the appropriate Quality stakeholders.
Vendor Quality Management
- Execute assigned activities within the risk-based vendor management program.
- Coordinate the collection and maintenance of vendor quality documentation.
- Support vendor qualification, periodic review, audit, and ongoing oversight activities as assigned.
- Track vendor-related quality issues, CAPAs, commitments, and follow-up activities.
- Maintain documentation supporting vendor qualification and oversight decisions.
- Work with internal stakeholders to obtain information required for vendor quality oversight and escalate vendor quality concerns and trends.
Quality and Compliance Support
- Support compliance with applicable GxP requirements, company policies, SOPs, and quality standards.
- Assist with preparation and maintenance of procedures, work instructions, and other controlled documents related to vendor and audit management.
- Identify potential compliance issues and escalate them through appropriate Quality channels.
- Support inspection and regulatory authority activities related to assigned vendor and audit records, as needed.
- Participate in cross-functional and global Quality initiatives as assigned.
Education/Certification Requirements:
Bachelor’s degree in a scientific, technical, quality, or related discipline
Knowledge, Skills, and Abilities:
- Approximately 7 or more years of pharmaceutical, biotechnology, Quality Assurance, auditing, vendor management, or related GxP experience preferred
- Experience supporting or managing GxP audits is strongly preferred.
- Experience working within an electronic quality management system; TrackWise Digital experience preferred.
- Experience working in a regulated pharmaceutical or biotechnology environment.
- Working knowledge of GxP requirements and Quality Assurance principles.
- Understanding of audit lifecycle management, including planning, reporting, CAPA follow-up, and closure.
- Strong organizational and project-management skills, with the ability to manage multiple concurrent activities and deadlines.
- Strong attention to detail and ability to maintain accurate and complete quality records.
- Ability to identify potential compliance concerns, apply sound judgment, and escalate appropriately.
- Strong written and verbal communication skills.
- Ability to work effectively with vendors, auditors, Quality personnel, and cross-functional stakeholders.
- Problem-solving and risk-analysis skills and the ability to interpret scientific, technical, procedural, and regulatory information.
- Proficiency in electronic quality systems and structured quality data management.
The pay range for this position at commencement of employment is expected to be between $131,750 - $155,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Location: Princeton, NJ
Location: Pleasanton, CA
#LI-Hybrid
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.
The incumbent in this position may be required to perform other duties, as assigned.
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us.
Hybrid: 3-days per week on-site
Employee Value Proposition
At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an opportunity to contribute to Quality Assurance activities in a dynamic, collaborative, and global cross-functional environment.
Position Summary:
The Manager, Quality Assurance Operations – Vendor & Audit Management is responsible for the day-to-day execution and administration of the Quality Assurance vendor and audit management program under the strategic direction of the Director, Quality Assurance Operations. The position manages operational audit activities and associated records within TrackWise Digital (TWD), supporting the audit lifecycle from initiation and scheduling through reporting, CAPA follow-up, and closure. The Manager works with internal stakeholders, auditors, vendors, and Quality colleagues to ensure activities are completed accurately, consistently, and in accordance with applicable procedures and regulatory expectations.
Performance Objectives:
Audit Management
- Coordinate the operational lifecycle of assigned GxP audits, including vendor audits and other Quality audits.
- Schedule audits and coordinate logistics with auditors, vendors, and internal stakeholders.
- Support audit preparation by collecting relevant documentation and ensuring required information is available.
- Maintain audit records and track activities through report issuance, response, CAPA management, follow-up, and closure.
- Monitor commitments and due dates and follow up with responsible stakeholders to support timely completion.
- Escalate significant compliance concerns, overdue activities, and emerging risks to the Director and appropriate Quality leadership.
TrackWise Digital Administration
- Perform day-to-day data entry and record maintenance for vendor and audit management activities in TWD.
- Create and maintain accurate audit and vendor records and supporting documentation.
- Track assigned actions, CAPAs, due dates, status changes, and closure activities in TWD.
- Perform routine data-quality checks to support the completeness, accuracy, and consistency of records.
- Support generation of audit and vendor management data for periodic reporting, metrics, trending, and management review.
- Identify data or workflow issues and escalate them to the appropriate Quality stakeholders.
Vendor Quality Management
- Execute assigned activities within the risk-based vendor management program.
- Coordinate the collection and maintenance of vendor quality documentation.
- Support vendor qualification, periodic review, audit, and ongoing oversight activities as assigned.
- Track vendor-related quality issues, CAPAs, commitments, and follow-up activities.
- Maintain documentation supporting vendor qualification and oversight decisions.
- Work with internal stakeholders to obtain information required for vendor quality oversight and escalate vendor quality concerns and trends.
Quality and Compliance Support
- Support compliance with applicable GxP requirements, company policies, SOPs, and quality standards.
- Assist with preparation and maintenance of procedures, work instructions, and other controlled documents related to vendor and audit management.
- Identify potential compliance issues and escalate them through appropriate Quality channels.
- Support inspection and regulatory authority activities related to assigned vendor and audit records, as needed.
- Participate in cross-functional and global Quality initiatives as assigned.
Education/Certification Requirements:
Bachelor’s degree in a scientific, technical, quality, or related discipline
Knowledge, Skills, and Abilities:
- Approximately 7 or more years of pharmaceutical, biotechnology, Quality Assurance, auditing, vendor management, or related GxP experience preferred
- Experience supporting or managing GxP audits is strongly preferred.
- Experience working within an electronic quality management system; TrackWise Digital experience preferred.
- Experience working in a regulated pharmaceutical or biotechnology environment.
- Working knowledge of GxP requirements and Quality Assurance principles.
- Understanding of audit lifecycle management, including planning, reporting, CAPA follow-up, and closure.
- Strong organizational and project-management skills, with the ability to manage multiple concurrent activities and deadlines.
- Strong attention to detail and ability to maintain accurate and complete quality records.
- Ability to identify potential compliance concerns, apply sound judgment, and escalate appropriately.
- Strong written and verbal communication skills.
- Ability to work effectively with vendors, auditors, Quality personnel, and cross-functional stakeholders.
- Problem-solving and risk-analysis skills and the ability to interpret scientific, technical, procedural, and regulatory information.
- Proficiency in electronic quality systems and structured quality data management.
The pay range for this position at commencement of employment is expected to be between $131,750 - $155,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Location: Princeton, NJ
Location: Pleasanton, CA
#LI-Hybrid
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.
The incumbent in this position may be required to perform other duties, as assigned.
See all 3,410+ Quality Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Quality Manager roles.
Get Access To All JobsTips for Finding Visa Sponsorship as a Quality Manager
Align your degree to quality systems
Consular officers and USCIS adjudicators look for a direct link between your degree field and quality management. A degree in industrial engineering, manufacturing engineering, or quality assurance science strengthens your specialty occupation argument more than a general business degree.
Target cap-exempt employers strategically
Universities, nonprofit research institutions, and government-affiliated organizations can file H-1B petitions outside the annual cap. Quality Manager roles in higher education facilities management or research lab operations often go overlooked by candidates chasing corporate openings.
Verify prevailing wage before negotiating salary
Your employer's LCA must certify a wage at or above the DOL prevailing wage for your location and role. Use the OFLC Wage Search to look up the Level I through Level IV wage tiers for Quality Manager positions in your target city before accepting an offer.
Use Migrate Mate to find verified sponsors
Quality Manager roles appear across manufacturing, medical devices, aerospace, and food production. Search Migrate Mate to find U.S. employers with verified LCA sponsorship history for quality roles, so you're applying to companies that have already navigated the filing process.
Prepare documentation for PERM early
If your employer plans to sponsor a green card through the EB-2 or EB-3 category, PERM labor certification requires documented recruitment efforts. Quality Managers with two or more years of experience typically qualify for EB-3 skilled worker classification without an advanced degree.
Address the specialty occupation question directly
Quality Manager is not a narrowly defined STEM role, so USCIS sometimes issues RFEs questioning whether the position requires a specific bachelor's degree. Have your employer prepare a detailed job duties letter showing that the role demands specialized knowledge in quality systems, regulatory compliance, or statistical process control.
Frequently Asked Questions
Does a Quality Manager role qualify as a specialty occupation for H-1B purposes?
Yes, but the employer must demonstrate that the specific position requires at least a bachelor's degree in a directly related field such as industrial engineering, quality engineering, or a relevant technical discipline. Generic quality oversight roles that accept any bachelor's degree can trigger an RFE from USCIS. The job duties letter and position description are critical documents in making this case.
Which visa types support sponsorship for Quality Manager positions?
H-1B is the primary work visa for Quality Managers, covering specialty occupation roles with employer sponsorship and a Labor Condition Application filed with DOL. TN visa status is available to Canadian and Mexican nationals if the role fits a qualifying USMCA profession. EB-2 and EB-3 green card categories cover Quality Managers through PERM labor certification, with EB-3 applying to roles requiring two or more years of experience.
What degree does a Quality Manager need to qualify for H-1B sponsorship?
USCIS expects a bachelor's degree in a field directly related to the role. Industrial engineering, manufacturing engineering, quality assurance, mechanical engineering, and chemical engineering are common qualifying fields for Quality Manager positions. A degree in general business or management may not satisfy the specialty occupation standard unless the employer can show the specific duties require specialized technical knowledge.
How do I find Quality Manager jobs that offer visa sponsorship?
Migrate Mate lists Quality Manager positions with employers who have verified LCA sponsorship history, so you can focus your applications on companies that have already committed to sponsoring work visas. This saves time compared to applying broadly and asking about sponsorship late in the process.
Can a Quality Manager self-petition for a green card without employer sponsorship?
Self-petition is possible under the EB-1A extraordinary ability category, but Quality Managers rarely meet that standard without extensive published research, awards, or international recognition. The EB-2 National Interest Waiver is a more realistic option for Quality Managers who can show their work benefits the U.S. in a field of substantial merit, such as pharmaceutical quality systems or critical infrastructure manufacturing.
What is the prevailing wage requirement for sponsored Quality Manager jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.