New · posted Oct 17
Takeda · Pharmaceuticals
Computerized Systems Quality Assurance Lead
- Lexington, MA
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
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.
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.
What you need
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 on-going 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.
Pay
$116,000 – $182,270 a year
Employer providedTakeda 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.
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.
Where you'll work
Lexington, MAHybridOpen in Maps (opens in a new tab)
More jobs in Lexington, MAWorking conditions
Locations
Lexington, MACHE - Glattpark (Opfikon) - Zurich HQ, Zurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
Lexington, MA
Job Exempt
YesIt 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.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
Job intelligence
The context around this role
Live data · October 17, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts25 roles publishing pay
Senior & Principal roles in the US281 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $116,000 | — | $182,270 |
| Massachusetts (middle half) | $109,000 | $125,500 | $133,000 |
| All US (middle half) | $104,000 | $123,000 | $137,500 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 17, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 852 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems10
- GMP and compliance9
- Documentation and SOPs9
- Collaboration and leadership9
- Validation and qualification5
- Quality systems and risk2
- Lab testing and methods1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Takeda on Regulatory Jobs
- 41
- Open roles
- 39
- Distinct roles
- 16
- Locations
By discipline
- Regulatory19 46%
- Quality16 39%
- Compliance & Safety5 12%
By level
- Director22 54%
- Senior & Principal10 24%
- Manager5 12%
More roles at Takeda
- View role
Quality Operations, Analyst II, Floor Support
Alewife, MAAssociate & SpecialistBiotechnology$72K–$113K
- View role
Quality Performance & Value Lead
Libertyville, ILSenior & PrincipalPharmaceuticals$154K–$243K
- View role
Quality Lead Technician
Birmingham, ALSenior & PrincipalPharmaceuticals$40K–$57K
- View role
Quality Lead Technician
Fayetteville, NCSenior & PrincipalPharmaceuticals$42K–$59K
Similar Quality Assurance roles elsewhere
- View role
Specialist / Senior Specialist - Quality Assurance
Kiniksa Pharmaceuticals InternationalLexington, MASenior & PrincipalPharmaceuticals$108K
- View role
Quality Product Lead
Thermo Fisher ScientificPlainville, MASenior & PrincipalPharmaceuticals$104K–$156K
- View role
Sr Analyst Quality Assurance
Johnson & JohnsonRaritan, NJSenior & PrincipalPharmaceuticals$94K–$152K
- View role
Sr. Principal, Global Quality Systems Business Partner
Eli LillyIndianapolis, INSenior & PrincipalPharmaceuticals$101K–$172K
Computerized Systems Quality Assurance Lead at Takeda
Open until filled. $116K–$182K a year, employer provided.