TN Visa Quality Management Systems Jobs
Quality Management Systems professionals qualify for TN visa sponsorship under the USMCA's Engineer and Scientific Technician categories, depending on your credentials and role scope. Canadian citizens can apply at the border or port of entry. Mexican citizens require consular processing. Employers file no lottery petition, making QMS roles one of the more direct paths to U.S. authorization.
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Get Access To All JobsManager - Quality Management Systems
Position Summary:
- Work Schedule: M-F 8am-5pm
- 100% on-site
Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
Catalent Pharma Solutions in Madison, WI is hiring an Manager - Quality Management Systems. The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.
The Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, raw material testing and disposition, and training.
The Role:
- Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements.
- Accountable for the Investigation and CAPA Management Systems and the Change Control Program.
- Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems.
- Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification and implementation of improvement opportunities for established Quality Systems processes, procedures, and training to support Deviation, Out-of-Specification, CAPA and Change Control processes.
- Responsible for reporting and monitoring site wide metrics internally and to corporate on pre-defined basis.
- Responsible for presenting the status of the Quality System at the quarterly Quality Management Review.
- Develops and provides training to support consistent and effective execution of the Quality Systems.
- Serves as local TrackWise® Subject Matter Expert.
- Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations.
- Responsible for maintaining high level understanding of the Quality Management Systems and operations to provide oversight and decision making as appropriate in the absence of the QA Director.
- Provides technical assistance and training for personnel.
- Other duties as assigned.
The Candidate:
- Doctorate Degree in STEM discipline with minimum of 4 years related experience,
OR
- Master's Degree in STEM discipline with minimum of 7 years related experience,
OR
- Bachelor's Degree in STEM discipline with minimum of 9 years related experience,
- Leadership experience minimum of 4 years.
Why you should join Catalent:
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of PTO + 8 paid holidays
- Generous 401K match
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement - Let us help you finish your degree or start a new degree!
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Manager - Quality Management Systems
Position Summary:
- Work Schedule: M-F 8am-5pm
- 100% on-site
Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
Catalent Pharma Solutions in Madison, WI is hiring an Manager - Quality Management Systems. The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.
The Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, raw material testing and disposition, and training.
The Role:
- Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements.
- Accountable for the Investigation and CAPA Management Systems and the Change Control Program.
- Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems.
- Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification and implementation of improvement opportunities for established Quality Systems processes, procedures, and training to support Deviation, Out-of-Specification, CAPA and Change Control processes.
- Responsible for reporting and monitoring site wide metrics internally and to corporate on pre-defined basis.
- Responsible for presenting the status of the Quality System at the quarterly Quality Management Review.
- Develops and provides training to support consistent and effective execution of the Quality Systems.
- Serves as local TrackWise® Subject Matter Expert.
- Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations.
- Responsible for maintaining high level understanding of the Quality Management Systems and operations to provide oversight and decision making as appropriate in the absence of the QA Director.
- Provides technical assistance and training for personnel.
- Other duties as assigned.
The Candidate:
- Doctorate Degree in STEM discipline with minimum of 4 years related experience,
OR
- Master's Degree in STEM discipline with minimum of 7 years related experience,
OR
- Bachelor's Degree in STEM discipline with minimum of 9 years related experience,
- Leadership experience minimum of 4 years.
Why you should join Catalent:
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of PTO + 8 paid holidays
- Generous 401K match
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement - Let us help you finish your degree or start a new degree!
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
See all 236+ Quality Management Systems jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Quality Management Systems roles.
Get Access To All JobsTips for Finding TN Visa Sponsorship as a Quality Management Systems
Map your credentials to TN categories
QMS roles can qualify under Industrial Engineer, Management Consultant, or Scientific Technician depending on your duties. Confirm your degree field aligns with your job description before applying, since CBP officers evaluate both at entry.
Target manufacturers with ISO certification programs
Companies actively pursuing or maintaining ISO 9001, AS9100, or IATF 16949 certification consistently hire QMS professionals and are familiar with TN sponsorship. Search job postings that list audit, corrective action, or CAPA responsibilities as primary duties.
Request a support letter covering TN eligibility
Ask your prospective employer to draft an offer letter that specifies your professional category, degree requirement, and how your QMS duties align with that TN classification. CBP uses this letter to adjudicate your application at the port of entry.
Use Migrate Mate to find QMS roles with TN sponsorship
Filter for Quality Management Systems positions where employers have confirmed TN visa sponsorship using Migrate Mate. This narrows your search to companies already set up to support your application without requiring internal HR education about the TN process.
Prepare for Mexican consular processing timelines
Mexican citizens must schedule a consular interview before starting work, which adds lead time. Build at least four to eight weeks into your start date negotiation so your employer doesn't rescind an offer over delayed availability.
Clarify remote work arrangements before filing
TN status ties you to a specific employer and work location. If your QMS role involves remote work across multiple sites, confirm with your employer that the offer letter reflects your primary worksite to avoid CBP questions at entry or renewal.
Quality Management Systems jobs are hiring across the US. Find yours.
Find Quality Management Systems JobsQuality Management Systems TN Visa: Frequently Asked Questions
Does a Quality Management Systems role qualify for TN visa status?
It depends on how your duties are classified. QMS roles most commonly qualify under the Industrial Engineer or Management Consultant TN categories. Your job title alone does not determine eligibility. CBP evaluates your actual responsibilities and your degree field at the port of entry, so your offer letter and credentials need to align precisely with the category you claim.
How does TN visa sponsorship for QMS jobs compare to H-1B?
TN has no annual cap for Canadian citizens and no lottery for any applicant, so you can start work as soon as CBP approves your application at the border or consulate. H-1B requires your employer to enter a lottery that selects roughly one in four registrants. For QMS professionals from Canada or Mexico, TN is typically faster, cheaper for employers, and more predictable.
Where can I find QMS employers who already sponsor TN visas?
Use Migrate Mate to search for Quality Management Systems positions with confirmed TN visa sponsorship. Most general job boards don't filter by visa type, so you risk spending time applying to employers who are unfamiliar with TN requirements or unwilling to provide the necessary offer letter and documentation.
Can a Canadian QMS professional apply for TN status at the U.S. border?
Yes. Canadian citizens can apply for TN status at any U.S. land border crossing or preclearance airport. You bring your offer letter, educational credentials, and supporting documents. CBP adjudicates the application on the spot, usually within an hour. No visa stamp is required, which makes the process significantly faster than consular processing for Mexican applicants.
What happens to my TN status if my QMS employer is acquired or restructures?
A corporate acquisition or merger can affect your TN status if your employing entity changes. If the acquiring company assumes your employment relationship under the same terms, USCIS generally allows continuation of status. If your role, employer of record, or job duties change materially, your employer should file a new TN petition or seek legal guidance before the change takes effect.
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