Green Card Director of Quality Jobs
Director of Quality jobs with green card sponsorship follow the EB-2 or EB-3 employment-based path, requiring PERM labor certification before your employer files an I-140 petition with USCIS. Per-country backlogs mean priority dates matter, so starting the process early with a sponsoring manufacturer, medtech firm, or regulated-industry employer gives you the strongest position.
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General Summary:
The Senior Director, Device Quality provides strategic Quality leadership and oversight for Vertex device and combination product operations across development, manufacturing, testing, clinical, commercial, and post-market activities.
The role is accountable for risk-based operational Quality oversight of internal activities and external partners, including CDMOs, testing laboratories, and critical suppliers. The role ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global device and combination product requirements.
The Senior Director serves as the Management Representative for the Device QMS, providing leadership for QMS effectiveness, regulatory compliance, management review, inspection readiness, and continual improvement. The role partners with senior Quality and business leaders on enterprise Quality initiatives.
Key Duties and Responsibilities:
-
Define and execute the Device Operational QA strategy aligned with business, portfolio, and product priorities.
-
Provide Quality oversight of CDMOs, suppliers, testing laboratories, and other external partners, including quality agreements, audits, performance, and risk management.
-
Provide Quality oversight of internal design control, design transfer, manufacturing, testing, and product realization activities.
-
Serve as Management Representative for the Device QMS, ensuring QMS effectiveness, management review, compliance, and continual improvement.
-
Ensure compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
-
Provide strategic oversight of deviations, investigations, CAPA, change control, complaints, supplier quality, audits, and inspection readiness.
-
Establish and monitor Quality metrics, risks, trends, and performance, driving timely escalation and resolution of significant issues.
-
Provide Quality leadership for regulatory inspections, notified body audits, product milestones, and launch readiness.
-
Partner with senior leaders on enterprise-wide Quality initiatives that improve compliance, operational effectiveness, and business performance.
-
Build organizational capability through talent development, coaching, and strong cross-functional leadership.
Knowledge and Skills:
-
Broad expertise in Device and Combination Product Quality Assurance, QMS, and operational Quality oversight.
-
Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
-
Demonstrated experience with CDMO/external partner oversight, supplier Quality, testing, audits, and inspection readiness.
-
Strong understanding of design controls, design transfer, risk management, manufacturing controls, supplier controls, and product realization.
-
Proven experience with CAPA, investigations, deviations, change control, complaints, and quality risk management.
-
Demonstrated capability to serve as Management Representative, including QMS performance, management review, compliance oversight, and risk escalation.
-
Strong strategic thinking, business acumen, risk-based decision-making, and problem-solving skills.
-
Ability to influence senior leaders and drive outcomes in a complex, matrixed organization.
-
Demonstrated leadership in cross-functional strategic initiatives.
-
Strong people leadership skills with demonstrated ability to develop talent, build organizational capability, and foster Quality ownership.
Education and Experience:
Bachelors degree in a scientific, allied health, or operations research field. Typically requires 15 years of relevant work experience and 5 years of supervisory/management experience or the equivalent combination of education and experience.
LI-Hybrid
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Pay Range:
$213,600 - $320,400
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:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
-
Hybrid: work remotely up to two days per week; or select
-
On-Site: 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.
LI-Hybrid
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 Senior Director, Device Quality provides strategic Quality leadership and oversight for Vertex device and combination product operations across development, manufacturing, testing, clinical, commercial, and post-market activities.
The role is accountable for risk-based operational Quality oversight of internal activities and external partners, including CDMOs, testing laboratories, and critical suppliers. The role ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global device and combination product requirements.
The Senior Director serves as the Management Representative for the Device QMS, providing leadership for QMS effectiveness, regulatory compliance, management review, inspection readiness, and continual improvement. The role partners with senior Quality and business leaders on enterprise Quality initiatives.
Key Duties and Responsibilities:
-
Define and execute the Device Operational QA strategy aligned with business, portfolio, and product priorities.
-
Provide Quality oversight of CDMOs, suppliers, testing laboratories, and other external partners, including quality agreements, audits, performance, and risk management.
-
Provide Quality oversight of internal design control, design transfer, manufacturing, testing, and product realization activities.
-
Serve as Management Representative for the Device QMS, ensuring QMS effectiveness, management review, compliance, and continual improvement.
-
Ensure compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
-
Provide strategic oversight of deviations, investigations, CAPA, change control, complaints, supplier quality, audits, and inspection readiness.
-
Establish and monitor Quality metrics, risks, trends, and performance, driving timely escalation and resolution of significant issues.
-
Provide Quality leadership for regulatory inspections, notified body audits, product milestones, and launch readiness.
-
Partner with senior leaders on enterprise-wide Quality initiatives that improve compliance, operational effectiveness, and business performance.
-
Build organizational capability through talent development, coaching, and strong cross-functional leadership.
Knowledge and Skills:
-
Broad expertise in Device and Combination Product Quality Assurance, QMS, and operational Quality oversight.
-
Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
-
Demonstrated experience with CDMO/external partner oversight, supplier Quality, testing, audits, and inspection readiness.
-
Strong understanding of design controls, design transfer, risk management, manufacturing controls, supplier controls, and product realization.
-
Proven experience with CAPA, investigations, deviations, change control, complaints, and quality risk management.
-
Demonstrated capability to serve as Management Representative, including QMS performance, management review, compliance oversight, and risk escalation.
-
Strong strategic thinking, business acumen, risk-based decision-making, and problem-solving skills.
-
Ability to influence senior leaders and drive outcomes in a complex, matrixed organization.
-
Demonstrated leadership in cross-functional strategic initiatives.
-
Strong people leadership skills with demonstrated ability to develop talent, build organizational capability, and foster Quality ownership.
Education and Experience:
Bachelors degree in a scientific, allied health, or operations research field. Typically requires 15 years of relevant work experience and 5 years of supervisory/management experience or the equivalent combination of education and experience.
LI-Hybrid
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Pay Range:
$213,600 - $320,400
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:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
-
Hybrid: work remotely up to two days per week; or select
-
On-Site: 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.
LI-Hybrid
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 158+ Green Card Director of Quality Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Green Card Director of Quality Jobs.
Get Access To All JobsTips for Finding Green Card Sponsorship in Director of Quality
Align your credentials to EB-2 requirements
EB-2 requires an advanced degree or a bachelor's degree plus five years of progressive quality-leadership experience. Document each promotion, expanded scope, and regulatory accountability with offer letters and performance records before you approach employers.
Target PERM-experienced regulated-industry employers
Manufacturers in aerospace, medtech, pharma, and automotive routinely sponsor Director of Quality roles because regulatory compliance demands permanent, senior leadership. Prioritize employers whose quality infrastructure is tied to FDA, ISO, or AS9100 certification requirements.
Search verified green card sponsors on Migrate Mate
Use Migrate Mate to find U.S. employers with confirmed EB-2 and EB-3 green card sponsorship history for quality and operations roles, searchable by city and industry, so you can focus outreach on companies that have already run the PERM process.
Check prevailing wage before salary negotiations
PERM requires your employer to pay at least the DOL prevailing wage for your SOC code and work location. Use OFLC Wage Search to look up the wage level for quality director roles in your target metro before you negotiate an offer.
Confirm the employer's PERM recruitment timeline upfront
PERM labor certification includes a mandatory recruitment test and can take six to twelve months before the I-140 is filed. Ask hiring managers whether they've run PERM before and whether they have immigration counsel in place, since inexperienced sponsors often underestimate the timeline.
Preserve your priority date if you change employers
Once your original I-140 is approved, your priority date can carry over to a new employer's I-140 petition. If your I-485 has been pending 180 days or more, AC21 portability lets you move to a same or similar occupation without restarting the green card process.
Green Card Director of Quality: Frequently Asked Questions
How does green card sponsorship for a Director of Quality role differ from H-1B sponsorship?
Green card sponsorship leads to lawful permanent residence, not a temporary work status. For Director of Quality roles, that means your employer must complete PERM labor certification with the Department of Labor, including a prevailing wage determination and a formal recruitment test proving no qualified U.S. worker was available. After PERM approval, they file an I-140 with USCIS. H-1B visa, by contrast, requires an LCA and has an annual lottery. EB-2 and EB-3 green cards have no lottery but do have per-country numerical limits that can create priority-date backlogs for nationals of high-demand countries.
Does a Director of Quality role qualify for EB-2 or EB-3 sponsorship?
Most Director of Quality positions qualify under EB-2 if the role requires an advanced degree or a bachelor's degree combined with five years of progressive quality-leadership experience. EB-3 is available for roles that require at least a bachelor's degree or two years of specialized experience. The employer's job description must accurately reflect the actual minimum requirements, since DOL scrutinizes whether the stated degree requirement is a genuine business necessity during PERM review.
How do I find employers who sponsor green cards for quality director roles?
Migrate Mate lists U.S. employers with verified EB-2 and EB-3 green card sponsorship history, searchable by role and city, so you can identify companies that have already completed the PERM process for quality and operations leadership positions. Focusing on regulated industries such as medtech, pharmaceutical manufacturing, and aerospace gives you the best concentration of employers with established green card sponsorship programs.
How long does the PERM process take for a Director of Quality position?
PERM labor certification typically takes six to twelve months from start to DOL approval, though DOL audit rates and processing backlogs can extend that timeline. After PERM approval, the employer files an I-140 with USCIS. For nationals of countries with per-country backlog limits, the wait for an available priority date can extend the overall timeline significantly. Starting the conversation with a sponsoring employer early in your job search is the most effective way to manage total processing time.
Can I change employers after my green card process has started?
Two distinct rules apply depending on your stage. Once your original I-140 petition is approved, your priority date can carry over to a new employer's I-140, so you don't lose your place in the queue. If your I-485 adjustment-of-status application has been pending for 180 days or more, AC21 job portability allows you to accept a position in the same or a similar occupation without the new employer restarting the PERM and I-140 process from the beginning.