Site Self Inspection Lead

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Viatris is dedicated to improving health outcomes globally. The Site Self-Inspection Lead role ensures GMP compliance and inspection readiness at the manufacturing site. The role leads self-inspections, conducts facility walk-throughs, manages the self-inspection program (scheduling, CAPAs, training), supports regulatory inspection readiness, participates in global audits, and audits third-party suppliers. This role acts as a key link between Site Leadership and Global Operations Auditing. The position will work with a high level of independence and actively coordinate with Global functions across Viatris.

• Creation and tracking of the site self-inspection plan, inclusive of self-inspection scheduling and development of self-inspection agenda.
• Liaising with Site Leadership and Global Operations Auditing to gain alignment on self-inspection plan schedule and scope.
• Leading and participating in site self-inspections. Ensuring each self-inspection is appropriately recorded and communicated. Performing frequent unplanned and planned walkthrough inspections of the facility.
• Evaluation and tracking of CAPA items from self-inspections and providing guidance to site functions to ensure robust, holistic actions are developed. Ensuring that CAPAs are verified for effectiveness.
• Prepare annual trend reports for site self-inspection data and collaborate across Viatris to identify Global and/or regional opportunities. Facilitate bi-monthly reviews with site and global personnel to discuss site learnings and opportunities.
• Responsible for Site Audit Module and associated processes and procedures.
• Support overall site Inspection Readiness Plan, participating as required in site Board of Health inspections.
• Participate in Global Operations Audits of Viatris facilities.
• Perform external audits of third party suppliers as aligned with site and GOA requirements.
• Participate in global audit training and disseminate relevant detail to site teams. Provide training and coaching as required to broader site self-inspection team.
• Support any of the site quality culture initiatives, and perform other duties as required by management.

• Minimum of a primary or higher degree in Science, Engineering, or related field with proven experience in GXP environments, including Quality Assurance.
• Strong understanding of cGMP and global regulatory requirements (FDA, WHO, EMA, ICH, ISO 9001), including Viatris policies and procedures.
• Proven leadership, accountability, and strong organizational skills; capable of working independently.
• Deep knowledge of quality systems and ability to apply global GMP standards to improve site systems and processes.
• Skilled in negotiation and collaboration with stakeholders at all levels, including senior leadership across Viatris.
• Strong command of written and spoken English is essential. Local language as required for specific site is essential.
• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors to communicate ambiguous concepts. Ability to present to groups across the organization.
• Audit qualification or training desired.
• Some travel expected. Potential for travel up to 20% of time.
• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.

Viatris is an Equal Opportunity Employer.