CSV Manager

About Viatris

Viatris is a global healthcare company blending generics and brand pharmaceuticals to comprehensively address global health challenges. Their mission is to empower people worldwide to live healthier lives at every stage, delivering high-quality medicines to nearly a billion patients annually. The company boasts a diverse portfolio, including iconic brand-name products, generics, and complex generics across many therapeutic areas. They focus on fostering healthier communities through education, outreach, and improved access to treatments. Viatris values courage, resilience, and collaboration, aiming to help employees realize their potential and make a meaningful impact.

Role Overview

The CSV (Computerized System Validation) Manager will be accountable for the preparation, execution, and reporting of GxP computerized systems validation activities at the site, ensuring regulatory compliance and adherence to company standards.

Key Responsibilities

• Prepare, execute, and report on GxP computerized systems validation deliverables at the site level.
• Ensure all validation procedures comply fully with relevant regulations and corporate policies.
• Maintain the validated status of all GxP computerized systems in use at the facility.
• Oversee the complete implementation lifecycle of assigned projects, monitoring progress, following up on open tasks, and handling escalations as necessary.
• Lead self-inspection and remediation processes related to GxP computerized systems.
• Conduct periodic reviews to confirm ongoing compliance of all computerized systems subject to GxP regulations.
• Contribute to the review and update of Computerized System Validation procedures.
• Manage Quality Management System responsibilities to ensure on-time completion of associated actions such as Change Controls, Deviations, investigations, and CAPAs.
• Review protocols, QMS documentation, CSV deliverables, and other relevant records for precision and compliance.
• Ensure readiness of the site for audits and actively participate during audit processes.
• Train cross-functional team members on CSV-related procedures and best practices.
• Keep an up-to-date inventory of GxP computerized systems at the site.

Required Skills and Experience

• Strong knowledge of regulatory requirements and industry standards concerning GxP computerized systems.
• Bachelor's degree or equivalent in Computer Science, Information Technology, Engineering, or related disciplines, supplemented by relevant experience. Equivalent combinations of education and experience will also be considered.
• Demonstrated capability to enforce compliance by executing CSV activities effectively.

Diversity and Inclusion

Viatris is committed to fostering a diverse, inclusive, and authentic work environment. Candidates whose experience doesn't fully align with all requirements are still encouraged to apply, as diverse backgrounds may fit this or other company roles.

Benefits

• Competitive compensation packages.
• Opportunities for professional growth and career advancement.
• Initiatives supporting work-life balance.
• Bonus programs.
• Health insurance.
• Pension schemes.

Corporate Social Responsibility

Viatris emphasizes sustainable and responsible business operations, aiming to empower healthier living across all life stages while considering their impacts on communities and stakeholders.

Equal Opportunity Employer

Viatris provides equal employment opportunities to all qualified candidates.