Remote (Global) Full-time

Viatris Pharmaceuticals S.L. is hiring a Manager QA IT - Based Anywhere in Europe

About the Role

McDermott Laboratories Limited At VIATRIS, we envision healthcare's transformative potential. We stand as a beacon of stability amid evolving medical landscapes. Viatris empowers global populations to achieve wellness across life stages through: Access – Delivering premium, reliable medications irrespective of geographical or socioeconomic barriers; Leadership – Pioneering sustainable methodologies and innovative solutions for enhanced patient outcomes; and Partnership – Strategically leveraging collective expertise to connect individuals with critical products and services. Our comprehensive portfolio encompasses premier branded pharmaceuticals, iconic global brands, generics including complex variations, and diverse therapeutic interventions. We are dedicated to cultivating healthier global communities via targeted education, strategic outreach, and enhanced treatment accessibility. For purpose-driven professionals, Viatris enables employees to maximize potential through a collaborative environment emphasizing courage and adaptability. Beyond a workplace, we offer a platform for meaningful global impact. The Role & Professional Responsibilities Daily, we embrace challenges to create substantial difference, with the Manager QA IT role driving critical organizational objectives: Computer System Validation (CSV) & IT Oversight - Direct and support validation processes for laboratory and manufacturing technological ecosystems. Ensure comprehensive compliance with regulatory frameworks. Review and authorize documentation related to computerized infrastructure. Quality & Compliance - Maintain rigorous data integrity across technological platforms. Develop comprehensive protocols and policies governing electronic systems and technological quality processes. Collaboration & Support - Interface between quality assurance, information technology, laboratory personnel, and operational teams. Conduct specialized training on data management, electronic record protocols, and system compliance. Risk & Security - Execute sophisticated risk assessments for technological infrastructures. Manage access controls, audit mechanisms, and cybersecurity considerations for regulated systems. Change management, procedural documentation, risk analysis, system validation, and periodic comprehensive reviews. Additional responsibilities as organizational requirements dictate. Candidate Requirements We seek professionals demonstrating: Bachelor's degree in Life Sciences, Computer Science, Information Technology, or related disciplines. Extensive pharmaceutical/biotech industry technological experience. Comprehensive understanding of regulatory landscapes including FDA, EMA, and ICH guidelines. Profound knowledge of laboratory and manufacturing computerized systems. Advanced capability to interpret and implement regulatory frameworks across digital platforms. Exceptional problem-solving, risk assessment, and documentation skills. Expertise in GAMP 5 computerized system guidelines. Superior analytical and communication capabilities. Mathematical proficiency involving complex computational tasks. Innovative problem-solving approach addressing multifaceted technological challenges. At Viatris, we celebrate diversity and encourage applications from candidates whose experiences might partially diverge from strict requirements. We offer competitive compensation, comprehensive benefits, and an inclusive environment fostering professional growth and meaningful societal contribution. Our commitment to diversity, equity, and sustainable operations defines our organizational philosophy. Viatris: An Equal Opportunity Employer.

Required Skills
Computer System Validation (CSV)Regulatory ComplianceData IntegrityRisk AssessmentIT Systems Management21 CFR Part 11GAMP 5 GuidelinesElectronic Records ManagementCybersecurityTechnical Documentation
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About company
Viatris Pharmaceuticals S.L.

Viatris provides high quality trusted medicines regardless of geography or circumstance. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.

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Job Details
Category qa_testing
Posted 4 months ago