STEM OPT Quality Manager Jobs
Quality Manager roles in manufacturing, biotech, and engineering align directly with STEM OPT eligibility, giving you up to 36 months of work authorization to build your career. Your employer must be enrolled in E-Verify to hire you, and your training plan must connect your STEM degree to the quality systems work you'll perform.
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Get Access To All JobsJob Description
General Summary: The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. This position performs and leads activities “on the floor” in support of batch records review and disposition while ensuring compliance with cGMPs policies and procedures. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects.
Key Duties And Responsibilities
- Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions
- Lead root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
- Perform change control assessments and closure approvals
- Establish and revise Quality Agreements between CMOs/Suppliers and Vertex, as needed
- Collect data and report on metrics
- Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills
- Lead continuous improvement projects
- Author SOP's to support commercial quality functions
- Assist with regulatory agency inspections
- Identify and facilitate continuous improvement efforts
- Train employees and provide insights and education on processes and procedures
- Perform activities associated with product disposition (e.g., batch document review, source data review etc.)
- Gown into cleanrooms and controlled environments
Knowledge And Skills
- Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting
- Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines
- Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint
- Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
- Formal project management experience
- Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences
- Able to integrate activities with other groups, departments and project teams as needed
- Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions
- Excellent team player and collaborator
- Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
Education And Experience
- Bachelor's degree in scientific or allied health field (or equivalent degree)
- Typically requires 4+ years of experience, or the equivalent combination of education and experience
Pay Range
$118,400 - $177,600
Disclosure Statement
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation
On-Site Designated
Flex Eligibility Status
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Job Description
General Summary: The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. This position performs and leads activities “on the floor” in support of batch records review and disposition while ensuring compliance with cGMPs policies and procedures. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects.
Key Duties And Responsibilities
- Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions
- Lead root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
- Perform change control assessments and closure approvals
- Establish and revise Quality Agreements between CMOs/Suppliers and Vertex, as needed
- Collect data and report on metrics
- Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills
- Lead continuous improvement projects
- Author SOP's to support commercial quality functions
- Assist with regulatory agency inspections
- Identify and facilitate continuous improvement efforts
- Train employees and provide insights and education on processes and procedures
- Perform activities associated with product disposition (e.g., batch document review, source data review etc.)
- Gown into cleanrooms and controlled environments
Knowledge And Skills
- Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting
- Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines
- Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint
- Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
- Formal project management experience
- Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences
- Able to integrate activities with other groups, departments and project teams as needed
- Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions
- Excellent team player and collaborator
- Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
Education And Experience
- Bachelor's degree in scientific or allied health field (or equivalent degree)
- Typically requires 4+ years of experience, or the equivalent combination of education and experience
Pay Range
$118,400 - $177,600
Disclosure Statement
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation
On-Site Designated
Flex Eligibility Status
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
See all 140+ Quality Manager jobs
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Get Access To All JobsTips for Finding STEM OPT Authorization as a Quality Manager
Verify your CIP code before applying
STEM OPT eligibility depends on your degree's Classification of Instructional Programs code, not just the degree name. Cross-reference your I-20's CIP code against the DHS STEM Designated Degree Program List before targeting Quality Manager roles.
Confirm E-Verify enrollment before accepting offers
Your employer must be actively enrolled in E-Verify before you can start on STEM OPT extension. Check the E-Verify employer search tool directly to confirm enrollment status, not just the recruiter's word during negotiations.
Target manufacturers with ISO or FDA audit history
Quality Manager roles at ISO 9001-certified manufacturers and FDA-regulated facilities map cleanly to STEM OPT training plans because the quality systems work ties directly to engineering or science degrees, reducing I-983 approval friction with your DSO.
Build your I-983 training plan around measurable outcomes
Your DSO approves the I-983, so frame your Quality Manager duties in terms of specific STEM learning objectives: SPC analysis, CAPA methodology, or process validation. Vague job descriptions create back-and-forth delays that push back your start date.
Use Migrate Mate to filter for E-Verify employers
Search Quality Manager roles on Migrate Mate, which filters positions by E-Verify enrollment status using DOL Labor Condition Application data. This removes the manual verification step and surfaces employers already set up to hire STEM OPT students.
Start H-1B cap-gap planning before your OPT expires
If your employer files an H-1B petition before your STEM OPT ends and you're selected in the lottery, cap-gap protection extends your work authorization through September 30. Coordinate your Quality Manager contract renewal timeline with your employer's USCIS filing calendar accordingly.
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Find Quality Manager JobsFrequently Asked Questions
Does a Quality Manager role qualify for STEM OPT extension?
Yes, if your degree carries a qualifying CIP code and your job duties connect directly to that STEM field. Quality Manager roles in manufacturing, engineering, or life sciences typically qualify because the work involves statistical process control, process engineering, or regulatory compliance grounded in STEM methodology. Your DSO makes the final determination when reviewing your I-983 training plan.
What must the I-983 training plan include for a Quality Manager position?
The I-983 must identify specific STEM learning objectives tied to your degree, not just a job description. For a Quality Manager, that means documenting how the role advances knowledge in areas like failure mode analysis, quality system design, or metrology. Your employer's supervisor signs off, your DSO reviews it, and USCIS can audit it at any point during your extension.
How do I confirm my employer is enrolled in E-Verify before my STEM OPT starts?
E-Verify enrollment is a legal prerequisite, not a formality. Use the E-Verify employer search tool to look up your employer's company name and confirm active participation status. Enrollment must be in place before your STEM OPT extension start date. If your employer isn't listed, they need to enroll before you can begin work under the extension.
What STEM degrees are typically eligible for Quality Manager STEM OPT roles?
Engineering disciplines (mechanical, industrial, chemical, electrical), materials science, physics, applied mathematics, and life sciences degrees commonly map to Quality Manager roles because the work involves quantitative analysis, process systems, and technical documentation. Your specific CIP code determines eligibility, so verify it on the DHS STEM Designated Degree Program List against your I-20 before targeting these positions.
Where can I find Quality Manager jobs where employers are already set up to hire STEM OPT students?
Migrate Mate filters Quality Manager roles by employers with E-Verify enrollment and DOL filing history, so you're not guessing about sponsorship willingness. This is especially useful for STEM OPT students because many employers support OPT work authorization but aren't yet familiar with the I-983 process, and filtering by verified E-Verify enrollment removes a significant screening step.
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