OPT QA Lead Jobs
QA Lead roles on OPT require demonstrating both technical testing expertise and team leadership, two things employers weigh heavily before committing to sponsorship. Your 12-month OPT window (29 months with a STEM extension) is enough time to prove both, especially in software-heavy industries where QA leads are consistently in demand.
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At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a QA Microbiology Specialist position within our Advanced Therapies Quality Assurance team. This position provides technical expertise and quality oversight for microbiology, contamination control, and microbial quality programs supporting Advanced Therapies operations. This role supports developing and overseeing microbiological control strategies, supports regulatory and compliance activities, supports driving platform-level microbial testing approaches, and serves as a key quality partner for process development, technology transfer, and external manufacturing operations.
When & Where
Location: East Greenbush, New York, United States
Work schedule: Monday-Friday, 8am-4:30pm
Discover Your Role
Microbiology & Contamination Control Support
Provide technical support and oversight for microbiological quality systems and contamination control programs, including:
- Support the development, implementation, and maintenance of contamination control strategies aligned with regulatory requirements and industry best practices.
- Review and assess environmental monitoring programs and associated data trends.
- Provide oversight and technical assessment of bioburden, endotoxin, and other microbiological testing activities.
- Conduct microbiological risk assessments and support implementation of mitigation actions.
- Technical support for regulatory submissions, inspections, and responses to Regulatory Information Requests.
Microbiology Program Development & Continuous Improvement
Contribute to the advancement of microbiology programs and initiatives by:
- Supporting the development and standardization of microbiological practices across Advanced Therapies programs.
- Participating in cross-functional discussions to align microbiological requirements and contamination control expectations.
- Identifying opportunities for process improvements and enhancements to microbial quality programs.
- Monitoring industry and regulatory trends to recommend enhancements to microbiological programs.
Technology Transfer, Sampling Plans & Process Support
Provide microbiology expertise to support manufacturing and product lifecycle activities, including:
- Review and approve microbiology-related sampling plans.
- Review Process Transmittal Requirement documents and technical transfer documentation.
- Support development and optimization of in-process, raw material, buffer, and product testing strategies.
- Partner with Manufacturing, Process Development, and Quality teams during technology transfer activities.
- Evaluate microbiological considerations associated with process changes and new product introductions.
Quality Event Review & Investigation Support
Support Microbiology-related Quality Systems And Issue Resolution Activities, Including:
- Review batch, release, and in-process testing deviations for microbiological impact.
- Assess microbiology-related deviations, nonconformances, and quality events.
- Participate in investigations, root cause analyses, and development of corrective and preventive actions (CAPAs).
- Support Quality Council discussions and other quality governance activities as needed.
- Assess microbiological impact of supplier changes, material changes, and manufacturing modifications.
- Provide technical recommendations to support product disposition and quality decisions.
Cross-Functional Partnership & Technical Expertise
- Serve as a microbiology subject matter expert within Quality and Manufacturing organizations.
- Provide technical guidance on microbiological testing, contamination control, and microbial risk management.
- Collaborate with internal and external stakeholders to support microbiological compliance and quality objectives.
- Share knowledge and mentor colleagues on microbiology-related processes and best practices.
- Promote a culture of quality, compliance, and continuous improvement.
This Role Requires
- Bachelor’s degree in Microbiology, Biological Sciences, Biotechnology, Pharmacy, or a related scientific discipline, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
+ Associate Specialist – 0-2 years
+ Specialist – 2+ years
+ Senior Specialist – 5+ years
+ Level will be determined based on experience
- Experience in pharmaceutical, biotechnology, cell and gene therapy, or advanced therapies manufacturing environments.
- Strong knowledge of Environmental monitoring programs, Contamination control strategies, Bioburden and endotoxin testing, Aseptic processing principles, Microbiological quality systems.
- Experience supporting investigations, deviations, CAPAs, and risk assessments.
- Familiarity with regulatory expectations and inspection readiness activities.
- Strong technical writing, communication, and cross-functional collaboration skills.
- Ability to independently assess microbiological risks and provide scientifically sound recommendations.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
For additional information about Regeneron benefits in the U.S., please visit the careers page. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
Salary Range (annually)
$62,355.00 - $128,700.00
Build Our Future Together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a QA Microbiology Specialist position within our Advanced Therapies Quality Assurance team. This position provides technical expertise and quality oversight for microbiology, contamination control, and microbial quality programs supporting Advanced Therapies operations. This role supports developing and overseeing microbiological control strategies, supports regulatory and compliance activities, supports driving platform-level microbial testing approaches, and serves as a key quality partner for process development, technology transfer, and external manufacturing operations.
When & Where
Location: East Greenbush, New York, United States
Work schedule: Monday-Friday, 8am-4:30pm
Discover Your Role
Microbiology & Contamination Control Support
Provide technical support and oversight for microbiological quality systems and contamination control programs, including:
- Support the development, implementation, and maintenance of contamination control strategies aligned with regulatory requirements and industry best practices.
- Review and assess environmental monitoring programs and associated data trends.
- Provide oversight and technical assessment of bioburden, endotoxin, and other microbiological testing activities.
- Conduct microbiological risk assessments and support implementation of mitigation actions.
- Technical support for regulatory submissions, inspections, and responses to Regulatory Information Requests.
Microbiology Program Development & Continuous Improvement
Contribute to the advancement of microbiology programs and initiatives by:
- Supporting the development and standardization of microbiological practices across Advanced Therapies programs.
- Participating in cross-functional discussions to align microbiological requirements and contamination control expectations.
- Identifying opportunities for process improvements and enhancements to microbial quality programs.
- Monitoring industry and regulatory trends to recommend enhancements to microbiological programs.
Technology Transfer, Sampling Plans & Process Support
Provide microbiology expertise to support manufacturing and product lifecycle activities, including:
- Review and approve microbiology-related sampling plans.
- Review Process Transmittal Requirement documents and technical transfer documentation.
- Support development and optimization of in-process, raw material, buffer, and product testing strategies.
- Partner with Manufacturing, Process Development, and Quality teams during technology transfer activities.
- Evaluate microbiological considerations associated with process changes and new product introductions.
Quality Event Review & Investigation Support
Support Microbiology-related Quality Systems And Issue Resolution Activities, Including:
- Review batch, release, and in-process testing deviations for microbiological impact.
- Assess microbiology-related deviations, nonconformances, and quality events.
- Participate in investigations, root cause analyses, and development of corrective and preventive actions (CAPAs).
- Support Quality Council discussions and other quality governance activities as needed.
- Assess microbiological impact of supplier changes, material changes, and manufacturing modifications.
- Provide technical recommendations to support product disposition and quality decisions.
Cross-Functional Partnership & Technical Expertise
- Serve as a microbiology subject matter expert within Quality and Manufacturing organizations.
- Provide technical guidance on microbiological testing, contamination control, and microbial risk management.
- Collaborate with internal and external stakeholders to support microbiological compliance and quality objectives.
- Share knowledge and mentor colleagues on microbiology-related processes and best practices.
- Promote a culture of quality, compliance, and continuous improvement.
This Role Requires
- Bachelor’s degree in Microbiology, Biological Sciences, Biotechnology, Pharmacy, or a related scientific discipline, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
+ Associate Specialist – 0-2 years
+ Specialist – 2+ years
+ Senior Specialist – 5+ years
+ Level will be determined based on experience
- Experience in pharmaceutical, biotechnology, cell and gene therapy, or advanced therapies manufacturing environments.
- Strong knowledge of Environmental monitoring programs, Contamination control strategies, Bioburden and endotoxin testing, Aseptic processing principles, Microbiological quality systems.
- Experience supporting investigations, deviations, CAPAs, and risk assessments.
- Familiarity with regulatory expectations and inspection readiness activities.
- Strong technical writing, communication, and cross-functional collaboration skills.
- Ability to independently assess microbiological risks and provide scientifically sound recommendations.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
For additional information about Regeneron benefits in the U.S., please visit the careers page. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
Salary Range (annually)
$62,355.00 - $128,700.00
See all 463+ OPT QA Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT QA Lead Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in QA Lead
Target companies with active STEM OPT hiring history
Companies that have sponsored STEM OPT extensions before are far more likely to do it again. Look for employers in software, fintech, and healthtech, where QA Lead roles regularly qualify under computer science or information technology degree categories.
Clarify your STEM extension eligibility upfront
QA Lead roles typically qualify for the 24-month STEM OPT extension if your degree is in computer science, information systems, or a related field. Confirm your degree's CIP code with your DSO before applying so you can answer employer questions confidently.
Frame your leadership experience in technical terms
Employers sponsoring OPT want evidence you can lead QA processes, not just execute them. Quantify your impact: test coverage improvements, defect reduction rates, and team size you managed all signal readiness for a lead-level role worth sponsoring.
Prioritize mid-sized tech companies over large enterprises
Mid-sized software companies often have more hiring flexibility and faster decision cycles than large enterprises. They also tend to have fewer bureaucratic hurdles around OPT sponsorship, making them a practical target for QA Lead candidates on a time-sensitive authorization window.
Address OPT authorization proactively in your application
Don't wait for employers to ask. A brief note in your cover letter stating you're authorized to work on OPT and eligible for a STEM extension reduces uncertainty and signals professionalism, both of which matter when a company is weighing sponsorship commitment.
Align your EAD start date with your job search timeline
You can't start work as a QA Lead until your EAD card arrives and your OPT start date is reached. Plan your job search to close offers 3 to 4 weeks before your EAD is valid, so onboarding aligns with when you're actually authorized.
QA Lead OPT: Frequently Asked Questions
Do QA Lead roles qualify for the STEM OPT extension?
Most QA Lead positions qualify for the 24-month STEM OPT extension if your degree is in computer science, information systems, software engineering, or a closely related field. The role must involve work directly related to your STEM degree. Your employer also needs to be enrolled in E-Verify, which most mid-to-large tech companies already are. Confirm your degree's CIP code with your DSO before assuming eligibility.
How do I find QA Lead jobs that are open to OPT candidates?
Migrate Mate filters jobs specifically for F-1 OPT students, so you're not wasting time applying to roles where employers have already ruled out work authorization. QA Lead listings on Migrate Mate are sourced from companies with demonstrated sponsorship activity, which meaningfully improves your odds compared to applying broadly through general job boards.
Can I work as a QA Lead while waiting for my STEM OPT extension to be approved?
Yes, as long as your initial OPT EAD is still valid and you filed your STEM extension application before it expired. USCIS automatically provides a 180-day cap-out extension while your STEM application is pending, so you can continue working without interruption. Keep a copy of your timely-filed application on hand and notify your employer's HR team so they're aware of your authorization status.
What makes a QA Lead role different from a regular QA Engineer role when it comes to OPT sponsorship?
Lead-level roles signal higher value to employers, which can make them more willing to invest in sponsorship. A QA Lead is typically responsible for test strategy, process ownership, and managing junior testers, not just executing test cases. That scope makes the role harder to fill quickly, giving you stronger leverage in sponsorship conversations. It also increases the likelihood an employer will pursue H-1B visa sponsorship after your OPT period ends.
What should I know about the 60-day grace period if I lose a QA Lead job while on OPT?
If your employment ends before your OPT EAD expires, you have a 60-day grace period to find new employment, transfer to a different visa status, or depart the United States. You cannot work during this grace period. If you're on a STEM extension, the same 60-day rule applies. Report the job loss to your DSO promptly since they're required to update your SEVIS record, and start your next job search immediately.