Quality Lead Visa Sponsorship Jobs in Massachusetts
Quality lead jobs in Massachusetts span life sciences, defense, and advanced manufacturing, with major employers like Raytheon Technologies, Boston Scientific, and Thermo Fisher Scientific actively hiring. Roles concentrate in Greater Boston, the Route 128 corridor, and Worcester. International candidates with engineering or science backgrounds pursue H-1B visa or employment-based green card sponsorship for these positions.
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OBJECTIVES:
Computerized Systems Quality Assurance (CS QA) Lead helps deliver on Takeda´s commitments for patient Safety, Product quality and data integrity by ensuring the quality and regulatory compliance of computerized systems and regulated data. This is accomplished by providing independent oversight of computerized system validation and operational activities to confirm that computerized systems and regulated data are maintained in compliance with applicable Healthcare Laws and regulations, and Takeda policies and procedures. The CS QA Lead also drives and sustains improvements to computerized systems and the processes for implementing and supporting them.
ACCOUNTABILITIES:
- Provides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.
- Promote and champion support of compliance, quality and best practice-oriented culture regarding Computerized systems.
- Authorize validation deliverables produced for global computerized system projects, including operational procedures, maintenance procedures and change requests.
- Support the development of global CS QA related procedures.
- Participate in ongoing operational management activities for global systems including, but not limited to demand management, Change Advisory Board and Quality Metrics.
- Support qualification activities for global computerized system vendors and 3rd party software providers including Cloud providers and SaaS solutions.
- Provide expertise and support during audits and inspections of Takeda.
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Proactively identify risks and issues. Drive implementation of pragmatic, Compliant, risk-based solutions.
- Lead ongoing initiatives and improvement projects in areas related to computerized systems and regulated data, as assigned.
- Proactively identify and share emerging industry standards/trends with business partners in the area of regulated computerized systems and regulated data.
- Support the response and remediation of corrective actions and internal audits.
- Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with Takeda procedures, regulatory requirements and industry standards.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor’s degree in science, Business, Engineering, IT or related discipline or 5 years of equivalent professional experience.
- Minimum 5 years of experience with FDA Regulations, ICH, EMA and/or other international healthcare regulations.
- Minimum 5 years of experience working with regulated IT systems and IT teams.
- Experience making quality assurance and compliance decisions in regard to software development, validation and support.
- Experience with all phases of software validation and infrastructure qualification.
- Experience with all phases of System Development Lifecycle principles, Processes and procedures.
- Demonstrated multitasking project management and execution skills.
- Ability to influence & negotiate with teams from all levels of the organization and external suppliers.
- Ability to read, analyze and interpret business plans technical procedures, and government regulations.
- Proven analytical and problem resolution skills; ability to identify root cause of problems.
- Excellent verbal and written communication skills at the functional and technical level.
- Ability to understand complex business processes and recommend simplification where possible.
- Documented experience in working as part of a virtual team.
- Proficient in Microsoft Office products.
Willingness to travel to various meetings or Takeda sites, including overnight trips.
Some international travel may be required.
Requires approximately 5-10% travel.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Base Salary Range:
$116,000.00 - $182,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Lexington, MA
Glattpark (Opfikon)
Zurich HQ, Zurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Job Description
OBJECTIVES:
Computerized Systems Quality Assurance (CS QA) Lead helps deliver on Takeda´s commitments for patient Safety, Product quality and data integrity by ensuring the quality and regulatory compliance of computerized systems and regulated data. This is accomplished by providing independent oversight of computerized system validation and operational activities to confirm that computerized systems and regulated data are maintained in compliance with applicable Healthcare Laws and regulations, and Takeda policies and procedures. The CS QA Lead also drives and sustains improvements to computerized systems and the processes for implementing and supporting them.
ACCOUNTABILITIES:
- Provides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.
- Promote and champion support of compliance, quality and best practice-oriented culture regarding Computerized systems.
- Authorize validation deliverables produced for global computerized system projects, including operational procedures, maintenance procedures and change requests.
- Support the development of global CS QA related procedures.
- Participate in ongoing operational management activities for global systems including, but not limited to demand management, Change Advisory Board and Quality Metrics.
- Support qualification activities for global computerized system vendors and 3rd party software providers including Cloud providers and SaaS solutions.
- Provide expertise and support during audits and inspections of Takeda.
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Proactively identify risks and issues. Drive implementation of pragmatic, Compliant, risk-based solutions.
- Lead ongoing initiatives and improvement projects in areas related to computerized systems and regulated data, as assigned.
- Proactively identify and share emerging industry standards/trends with business partners in the area of regulated computerized systems and regulated data.
- Support the response and remediation of corrective actions and internal audits.
- Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with Takeda procedures, regulatory requirements and industry standards.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor’s degree in science, Business, Engineering, IT or related discipline or 5 years of equivalent professional experience.
- Minimum 5 years of experience with FDA Regulations, ICH, EMA and/or other international healthcare regulations.
- Minimum 5 years of experience working with regulated IT systems and IT teams.
- Experience making quality assurance and compliance decisions in regard to software development, validation and support.
- Experience with all phases of software validation and infrastructure qualification.
- Experience with all phases of System Development Lifecycle principles, Processes and procedures.
- Demonstrated multitasking project management and execution skills.
- Ability to influence & negotiate with teams from all levels of the organization and external suppliers.
- Ability to read, analyze and interpret business plans technical procedures, and government regulations.
- Proven analytical and problem resolution skills; ability to identify root cause of problems.
- Excellent verbal and written communication skills at the functional and technical level.
- Ability to understand complex business processes and recommend simplification where possible.
- Documented experience in working as part of a virtual team.
- Proficient in Microsoft Office products.
Willingness to travel to various meetings or Takeda sites, including overnight trips.
Some international travel may be required.
Requires approximately 5-10% travel.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Base Salary Range:
$116,000.00 - $182,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Lexington, MA
Glattpark (Opfikon)
Zurich HQ, Zurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Quality Lead Job Roles in Massachusetts
See all 43+ Quality Lead Jobs in Massachusetts
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Search Quality Lead Jobs in MassachusettsQuality Lead Jobs in Massachusetts: Frequently Asked Questions
Which companies sponsor visas for quality leads in Massachusetts?
Life sciences and defense employers in Massachusetts have established sponsorship programs for quality lead roles. Companies such as Boston Scientific, Thermo Fisher Scientific, Raytheon Technologies, Hologic, and Moderna have filed Labor Condition Applications for quality and operations professionals. Larger manufacturers along the Route 128 corridor and in the Greater Boston area tend to have dedicated immigration support teams familiar with H-1B and green card processes for technical roles.
Which visa types realistically fit quality lead roles in Massachusetts?
Quality lead roles typically require a bachelor's degree in engineering, sciences, or a related field, which supports H-1B classification as a specialty occupation. Employers file a Labor Condition Application with DOL before submitting an H-1B petition with USCIS. H-1B status is granted for up to three years, extendable to six. For longer-term options, EB-2 or EB-3 employment-based green cards are common pathways, usually requiring PERM labor certification. TN visa does not cover quality lead roles.
How to find quality lead visa sponsorship jobs in Massachusetts?
Migrate Mate lists quality lead positions at Massachusetts employers with verified visa sponsorship history, searchable by city and role. This lets you focus on companies that have actively sponsored international workers in quality and operations functions rather than applying broadly. Concentrating your search on the Greater Boston area, Worcester, and the Route 128 technology corridor gives you access to the state's densest clusters of life sciences and advanced manufacturing employers.
Which cities in Massachusetts have the most quality lead sponsorship jobs?
Greater Boston and the surrounding Route 128 corridor account for the largest concentration of quality lead sponsorship activity in Massachusetts, driven by the density of medical device, pharmaceutical, and defense employers. Marlborough, Waltham, and Lexington host significant life sciences and technology operations. Worcester is a secondary hub with manufacturing and medical technology employers. Cambridge sees quality roles tied to biotechnology firms operating alongside major research institutions.
Are there any Massachusetts-specific factors that affect visa sponsorship for quality leads?
Massachusetts has an unusually deep life sciences and defense manufacturing base, which sustains consistent demand for quality professionals with technical degrees. The state's university ecosystem, including MIT, Northeastern, and UMass Amherst, creates a pipeline of engineering graduates familiar to local employers, making degree-based specialty occupation arguments for H-1B straightforward for qualified candidates. Quality lead roles tied to FDA-regulated products or defense contracts often require structured quality systems experience, which strengthens specialty occupation documentation for visa purposes.
What is the prevailing wage for sponsored quality lead jobs in Massachusetts?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.