Viatris · 1 week ago
Manager QA IT - Based Anywhere in Europe
United States
Full-time
Remote
Mid, Senior LevelViatris is a global healthcare company dedicated to empowering people worldwide to live healthier at every stage of life. The Manager QA IT role focuses on ensuring compliance and data integrity across laboratory and manufacturing systems while acting as a liaison between multiple departments to support quality management systems.
BiotechnologyHealth CareLife SciencePharmaceutical
Responsibilities
Lead and support validation activities for laboratory and manufacturing systems (LIMS, CDS, MES, EBR, QMS, etc.). Ensure systems comply with 21 CFR Part 11, Annex 11, and other applicable data integrity requirements. Review and approve user requirements, validation documentation, and change controls related to computerized systems
Ensure data integrity across all computerized systems in compliance with ALCOA+ principles. Develop and review protocols, and policies related to electronic systems and IT quality processes
Act as liaison between QA, IT, laboratory staff, and manufacturing operations. Train users on data integrity, electronic records, and compliance with IT-related systems. Support electronic quality management systems (QMS) for deviations, and change management
Conduct IT-related risk assessments for laboratory and manufacturing systems. Oversee access controls, audit trails, and cybersecurity considerations for regulated systems. Support disaster recovery planning and data backup/restore processes in alignment with compliance requirements
Change control, SOP/Guideline management, Risk Analysis, CSV lifecycle based on ISPE GAMP5 guidance, and Periodic Reviews
Perform other duties as assigned
Qualification
Required
Bachelor's degree in Life Sciences, Computer Science, Information Technology, or related field
Extensive years of experience in IT within a pharmaceutical, biotech, or medical device industry
Knowledge of FDA, EMA, and ICH regulations, including 21 CFR Part 11 and EU Annex 11
Experience with Computer System Validation (CSV)
Understanding of laboratory and manufacturing computerized systems (LIMS, CDS, MES, EBR, TrackWise, Master Control, etc.)
Ability to interpret regulatory requirements and apply them to IT and digital systems
Problem-solving, risk assessment, and documentation skills
Familiarity with GAMP 5 guidelines for computerized systems
Ability to read and interpret complex business and/or technical documents
Ability to write comprehensive reports and detailed business correspondence
Ability to perform computations such as percentages, ratios, and rates
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis
Benefits
Competitive salaries
Benefits
Career progression opportunities
Work-life balance initiatives
Company
Viatris
Viatris is a global pharmaceutical company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer.
Founded in 2020
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2020-11-17IPO
Leadership Team
Scott A. Smith
Chief Executive Officer
Doretta Mistras
Chief Financial Officer
Recent News
legacy.thefly.com
2026-01-21
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