OPT Quality Assurance Manager Jobs
Quality Assurance Manager jobs on OPT require employers to support your work authorization, whether through H-1B visa sponsorship before your OPT expires or an extension if your degree is in a STEM field. QA leadership roles qualify as specialty occupations, making them strong candidates for visa sponsorship.
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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 412+ OPT Quality Assurance Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Assurance Manager Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Assurance Manager
Lead with your QA methodology expertise
Employers sponsor QA Managers who bring specialized frameworks to the table. Highlight hands-on experience with Agile, Six Sigma, or ISO 9001 in your resume and cover letter. Methodology depth signals the kind of specialized knowledge that justifies H-1B visa sponsorship.
Target industries with strong sponsorship track records
Pharmaceutical, medical device, software, and semiconductor companies hire QA Managers regularly and have established visa sponsorship processes. These industries face strict regulatory compliance requirements, making experienced QA leadership a genuine business necessity, not a hiring preference.
Raise OPT status early in recruiter conversations
Mention your work authorization during the first recruiter call, not after an offer is extended. Framing it as a straightforward OPT-to-H-1B transition, with your end date and STEM eligibility if applicable, prevents late-stage surprises that can derail otherwise strong candidacies.
Quantify your quality impact with hard numbers
QA hiring decisions are data-driven. Include metrics like defect reduction percentages, audit pass rates, or cost savings from process improvements. Concrete outcomes make your case for sponsorship easier to justify internally when an employer's legal team reviews your petition.
Pursue relevant certifications before applying
Credentials like ASQ Certified Quality Manager, Six Sigma Black Belt, or PMP strengthen your specialty occupation argument. Certifications signal commitment to the field and reduce employer hesitation about sponsoring someone who may be early in their management career.
Identify STEM OPT eligibility before your standard OPT ends
If your degree is in engineering, computer science, or a related STEM field, you may qualify for a 24-month OPT extension. This gives employers significantly more runway to file your H-1B petition and reduces urgency that can make them hesitate to sponsor.
Quality Assurance Manager OPT: Frequently Asked Questions
Do Quality Assurance Manager roles qualify for H-1B sponsorship?
Yes. Quality Assurance Manager is generally accepted as a specialty occupation because it requires at least a bachelor's degree in a related field such as engineering, computer science, or a natural science. Employers in regulated industries like pharmaceuticals, medical devices, and software routinely sponsor QA Managers for H-1B petitions.
How do I find Quality Assurance Manager jobs that sponsor OPT students?
Migrate Mate filters job listings specifically for OPT-friendly employers, so you can browse Quality Assurance Manager openings without manually screening each company for sponsorship willingness. Searching through Migrate Mate surfaces roles where employers have an established history of supporting F-1 work authorization and H-1B sponsorship.
Can I work as a Quality Assurance Manager on STEM OPT extension?
Yes, if your degree falls under a qualifying STEM category such as industrial engineering, computer science, or a related field, and your employer is enrolled in E-Verify. The 24-month STEM OPT extension gives you time to work in a QA leadership role while your employer files your H-1B petition during the annual lottery.
What degree fields support a Quality Assurance Manager specialty occupation claim?
Engineering disciplines, computer science, chemistry, biology, and industrial technology are the most common supporting fields. The degree must be directly related to the duties of the QA role. A general business degree may not be sufficient unless paired with substantial technical coursework or relevant professional certifications like ASQ or Six Sigma credentials.
What should I do if my OPT ends before my employer files my H-1B petition?
If you have a timely filed H-1B petition with a requested start date of October 1 and your OPT authorization expires before then, a cap-gap provision automatically extends your work authorization. You can continue working legally in your QA Manager role during this period without interruption, provided your employer filed before your OPT expired.