{"id":2824638,"url":"https://alion.io/job/takeda-pharmaceutical-computerized-systems-quality-assurance-lead","title":"Computerized Systems Quality Assurance Lead","company":{"id":5984,"name":"Takeda Pharmaceutical","domain":"takeda.com","url":"https://alion.io/company/takeda","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":87,"open_postings":45,"ghost_share":0,"stale_share":0.533,"repost_share":0,"time_to_fill_p50_days":24,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Lexington, United States","Zurich, Switzerland","Opfikon, Switzerland"],"countries":["US","CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":116000,"max":182270,"currency":"USD","period":"year","gross":null,"usd_annual":182270},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-16T00:00:00Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-24T15:05:18Z","board_verified":false,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":11},"description":"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.\nJob Description\nOBJECTIVES:\nComputerized 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.\nACCOUNTABILITIES:\nProvides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.\n\nPromote and champion support of compliance, quality and best practice-oriented culture regarding Computerized systems.\n\nAuthorize validation deliverables produced for global computerized system projects, including operational procedures, maintenance procedures and change requests\n\nSupport the development of global CS QA related procedures\n\nParticipate in ongoing operational management activities for global systems including, but not limited to demand management, Change Advisory Board and Quality Metrics\n\nSupport qualification activities for global computerized system vendors and 3rd party software providers including Cloud providers and SaaS solutions.\n\nProvide expertise and support during audits and inspections of Takeda\n\nIdentify and report any quality or compliance concerns and take immediate corrective action as required\n\nProactively identify risks and issues. Drive implementation of pragmatic, Compliant, risk-based solutions\n\nLead on-going initiatives and improvement projects in areas related to computerized systems and regulated data, as assigned\n\nProactively identify and share emerging industry standards/trends with business partners in the area of regulated computerized systems and regulated data\n\nSupport the response and remediation of corrective actions and internal audits.\n\nCollaborate 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.\n\nEDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:\nBachelor’s degree in science, Business, Engineering, IT or related discipline or 5 years of equivalent professional experience.\n\nMinimum 5 years of experience with FDA Regulations, ICH, EMA and/or other international healthcare regulations.\n\nMinimum 5 years of experience working with regulated IT systems and IT teams\n\nExperience making quality assurance and compliance decisions in regard to software development, validation and support.\n\nExperience with all phases of software validation and infrastructure qualification.\n\nExperience with all phases of System Development Lifecycle principles, Processes and procedures.\n\nDemonstrated multitasking project management and execution skills\n\nAbility to influence & negotiate with teams from all levels of the organization and external suppliers.\n\nAbility to read, analyze and interpret business plans technical procedures, and government regulations\n\nProven analytical and problem resolution skills; ability to identify root cause of problems\n\nExcellent verbal and written communication skills at the functional and technical level.\n\nAbility to understand complex business processes and recommend simplification where possible.\n\nDocumented experience in working as part of a virtual team.\n\nProficient in Microsoft Office products\n\nWillingness to travel to various meetings or Takeda sites, including overnight trips.\nSome international travel may be required.\nRequires approximately 5-10% travel.\nMore about us:\nAt 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.\nCertified 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.\nThis position is currently classified as \"hybrid\" in accordance with Takeda's Hybrid and Remote Work policy.\nTakeda Compensation and Benefits Summary\nWe understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.\nFor Location:\nLexington, MAU.S. Base Salary Range:\n$116,000.00 - $182,270.00The 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.\nFor information about our benefits, please click here.\nEEO Statement\nTakeda 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.\nLocations\nLexington, MACHE - Glattpark (Opfikon) - Zurich HQ, Zurich, SwitzerlandWorker Type\nEmployeeWorker Sub-Type\nRegularTime Type\nFull timeJob Exempt\nYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. 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