CSV Manager

About Viatris

Viatris is a global healthcare organization committed to bridging the gap between generics and brand medicines to better meet global healthcare needs. Our mission is to empower individuals worldwide to achieve better health across all life stages by providing access to high-quality medicines to approximately one billion patients annually. Our broad product portfolio includes iconic brand-name products, key generics, including complex branded generics, spanning multiple therapeutic areas. We strive to improve global health through education, outreach, and enhanced treatment access. Viatris promotes a collaborative culture fostering courage and resilience, aiming to help employees realize their potential and make a meaningful impact worldwide.

Role Summary and Responsibilities

The CSV Manager will oversee the validation of GxP computerized systems on site, ensuring compliance with regulatory standards and company policies. Key duties include preparing, executing, and reporting validation deliverables, upholding the validated status of all relevant systems, managing projects from initiation through to completion, and addressing any escalations. The role also involves conducting self-inspections and remediation efforts related to GxP computerized systems, carrying out periodic compliance reviews, contributing to CSV procedure revisions, and managing quality management system (QMS) activities such as change controls, deviations, investigations, and CAPAs. The manager will review protocols and documentation for accuracy, prepare the site for internal and external audits, train cross-functional teams on CSV procedures, and maintain an updated inventory of GxP systems.

Candidate Profile and Qualifications

We seek candidates with robust expertise in regulatory requirements and industry standards relating to GxP computerized systems. A minimum of a Bachelor's degree (or equivalent) in computer science, IT, engineering, or a related discipline with relevant experience is expected; however, a mix of experience and education will also be considered. The ideal candidate should be adept at driving compliance through diligent execution of CSV activities.

Benefits and Additional Information

Viatris offers competitive salaries, comprehensive benefits, and a nurturing, inclusive environment. Benefits include career advancement opportunities, work-life balance initiatives, bonus schemes, health insurance, and pension plans. The company is dedicated to fostering diversity, equity, and inclusion as core values that strengthen our mission. Sustainability and corporate social responsibility are integral to Viatris, with ongoing efforts to ensure responsible and sustainable business operations.

Diversity and Inclusion

Diversity and inclusion are foundational to our culture at Viatris. We believe diverse perspectives and backgrounds fuel innovation and redefine healthcare. Candidates from all backgrounds are encouraged to apply, even if their experience does not perfectly match every requirement.

Equal Opportunity

Viatris is committed to equal employment opportunities for all.