OPT Quality Assurance Lead Jobs
Quality Assurance Lead roles are well-suited for F-1 OPT students with degrees in computer science, software engineering, or information systems. Most positions fall under STEM OPT extension-eligible SOC codes, giving you up to 36 months of work authorization. Strong QA backgrounds in test automation and team coordination translate directly into roles that actively sponsor visas.
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Get Access To All JobsJob Title: Quality Assurance Specialist
- Location: Framingham, MA
About the Job
Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.
Main Responsibilities
The Quality Assurance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Quality Assurance Specialist is also responsible for mentoring and supporting the junior staff.
Core Responsibilities include:
- Provide Gemba Support
- Perform batch record review
- Perform review of column packing and qualification records
- Function as SME on input related to quality decisions
- Approve Non-conforming material discards
- Perform log book review
- Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
- Issue action notices and conduct affiliated provisional release
- Conduct log book audits against compliance requirements
- Review Cleaning Verification (CV) related documentation against specification
- Perform media / buffer and intermediate release
- Prepare Bioreactor summary
- Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walkthrough inspections
- Execute containment activities
- Provide off-hour support for batch record and log book issuance
- Partner with manufacturing and support operations to ensure a culture of continuous compliance
- May provide training to new employees
- Revise procedures / SOPs
- Initiate and Investigate and QA review deviations
- Review NRSR (Non-Routine Sample Requests)
- Other activities as assigned
- Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
Leadership Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:
- Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
About You
Basic Qualifications
- Bachelor’s Degree in a scientific field and 4 years of related experience, associate’s degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and/or other CGMP related field.
- Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and/or cGMP environment.
- Basic to Intermediate computer proficiency, strong verbal and written communication skills.
- Experience with quality systems and cGMP data review
Preferred Qualifications:
- Bachelor’s degree in a scientific field with 4 years of experience in a Quality and/or cGMP environment.
- Experience in bio-pharmaceutical industry.
- Strong technical writing skills
- Effective time management, attention to detail, organizational skills, teamwork and collaborations.
- Demonstrated competence in problem solving methodology.
- Experience participating and/or leading cross-functional project team collaborations.
Special Working Conditions:
- Ability to gown and gain entry to manufacturing areas
- Ability to work a 10-hour shift with rotating weekend coverage, including some holidays
- Ability to lift 10 lbs
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Quality Assurance Specialist
- Location: Framingham, MA
About the Job
Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.
Main Responsibilities
The Quality Assurance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Quality Assurance Specialist is also responsible for mentoring and supporting the junior staff.
Core Responsibilities include:
- Provide Gemba Support
- Perform batch record review
- Perform review of column packing and qualification records
- Function as SME on input related to quality decisions
- Approve Non-conforming material discards
- Perform log book review
- Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
- Issue action notices and conduct affiliated provisional release
- Conduct log book audits against compliance requirements
- Review Cleaning Verification (CV) related documentation against specification
- Perform media / buffer and intermediate release
- Prepare Bioreactor summary
- Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walkthrough inspections
- Execute containment activities
- Provide off-hour support for batch record and log book issuance
- Partner with manufacturing and support operations to ensure a culture of continuous compliance
- May provide training to new employees
- Revise procedures / SOPs
- Initiate and Investigate and QA review deviations
- Review NRSR (Non-Routine Sample Requests)
- Other activities as assigned
- Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
Leadership Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:
- Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
About You
Basic Qualifications
- Bachelor’s Degree in a scientific field and 4 years of related experience, associate’s degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and/or other CGMP related field.
- Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and/or cGMP environment.
- Basic to Intermediate computer proficiency, strong verbal and written communication skills.
- Experience with quality systems and cGMP data review
Preferred Qualifications:
- Bachelor’s degree in a scientific field with 4 years of experience in a Quality and/or cGMP environment.
- Experience in bio-pharmaceutical industry.
- Strong technical writing skills
- Effective time management, attention to detail, organizational skills, teamwork and collaborations.
- Demonstrated competence in problem solving methodology.
- Experience participating and/or leading cross-functional project team collaborations.
Special Working Conditions:
- Ability to gown and gain entry to manufacturing areas
- Ability to work a 10-hour shift with rotating weekend coverage, including some holidays
- Ability to lift 10 lbs
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
GD-SG
LI-GZ
vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
See all 413+ OPT Quality Assurance Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Assurance Lead Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Quality Assurance Lead
Target companies with established QA teams
Large software, fintech, and healthcare technology companies run dedicated QA organizations and have existing H-1B visa sponsorship pipelines. These employers understand the visa process and are far more likely to sponsor than startups hiring their first QA engineer.
Emphasize your automation skills front and center
QA Lead roles requiring Selenium, Cypress, or Playwright are consistently harder to fill than manual testing roles. Employers sponsoring visas want proven ROI. Automation expertise signals that you're solving a skill gap, which makes sponsorship a much easier internal conversation.
Frame leadership experience in your resume clearly
QA Lead implies people management or at minimum cross-functional coordination. Spell out team size, reporting structure, and the scope of your test strategy ownership. Vague leadership claims reduce your competitiveness against candidates with clearly documented lead experience.
Apply during your OPT window, not after
Start your search at least three months before your initial OPT expires. Employers who are willing to sponsor need time to file the H-1B or consider E-3 visa or TN visa options. Waiting until the final weeks dramatically limits which employers can realistically move forward.
Prioritize STEM-eligible roles to maximize your timeline
Confirm the job posting's SOC code aligns with STEM OPT extension eligibility before applying. QA Lead roles under software quality assurance engineering SOC codes typically qualify. The 24-month extension gives employers a longer runway to complete H-1B sponsorship.
Address sponsorship directly and early in conversations
Bring up your OPT status and visa needs in the first recruiter screen, not after an offer. Employers who cannot sponsor will tell you immediately, saving both sides weeks of time. Employers who can sponsor appreciate the transparency and will plan accordingly.
Quality Assurance Lead OPT: Frequently Asked Questions
Do Quality Assurance Lead roles typically qualify for the STEM OPT extension?
Most QA Lead roles qualify for the 24-month STEM OPT extension when the position falls under a STEM-designated SOC code, such as software quality assurance engineers and testers. Your degree field also matters. Degrees in computer science, information systems, or software engineering generally satisfy the STEM OPT extension requirements. Confirm the SOC code with your employer's HR team before applying for the extension.
How common is H-1B sponsorship for Quality Assurance Lead positions?
Sponsorship rates are meaningfully higher for QA Lead roles than for entry-level QA positions because the lead-level skill set, particularly test automation and team oversight, is harder to source domestically. Mid-size and enterprise software companies, especially in fintech, healthtech, and SaaS, are the most consistent sponsors. Migrate Mate lists QA Lead openings filtered by sponsorship availability so you can focus your applications on employers already open to sponsoring.
Can I work as a Quality Assurance Lead on OPT if my degree is in a non-engineering field?
It depends on whether your degree has a direct connection to the role. OPT authorizes work directly related to your major area of study. A degree in information technology, computer science, or a related technical field has a clear connection to QA Lead work. A degree in business or communications would require a stronger case. Your DSO can help you assess whether the role qualifies under your specific degree program.
What visa options are available after OPT expires for a Quality Assurance Lead?
The H-1B is the most common path. QA Lead roles meet the specialty occupation standard because they require a bachelor's degree or higher in a specific technical field. If you're an Australian citizen, the E-3 visa is a faster and lottery-free alternative. Canadian and Mexican nationals may qualify under TN status. Your employer initiates all of these petitions, so identifying a sponsoring employer during your OPT window is the critical first step.
How should I handle the gap between OPT expiration and H-1B approval as a QA Lead?
If your employer files an H-1B cap-subject petition before your OPT expires and you have a valid STEM OPT extension in place, the cap-gap rule allows you to continue working through September 30 of that year. This requires your STEM OPT extension to be timely filed and your employer to submit the H-1B petition before the April 1 filing window opens. Work closely with your employer's immigration attorney to ensure no authorization gap occurs.