Site Self Inspection Lead

Site Self Inspection Lead

Requirements

• Bachelor’s degree in Science, Engineering, or related technical discipline from a four-year college or university is required. MBA is a plus.
• Minimum 10 years’ experience in a GXP setting, extending across a range of functions inclusive of Quality Assurance.
• Extensive understanding of pharmaceutical cGMP and global government regulations, including Viatris policies, procedures and associated documents (corporate, regional, site), local regulations, US FDA, WHO EMA, ICH and ISO 9001 (as applicable to the site).
• Possess an in-depth knowledge of quality system requirements; including a demonstrated ability to evaluate and apply global GMP’s to support evaluation and enhancement to site systems and processes.
• Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision.
• Comprehensive and demonstrated written and verbal communication skills are required.
• Demonstrated ability to negotiate and collaborate with individuals and groups at multiple levels across the organization including senior leadership of various functional lines across Viatris.
• Travel Expectation: Some travel expected. Potential for travel up to 20% of time.

Responsibilities

• Collaborate between Global Operations Auditing and Site Leadership, providing key regulatory GMP knowledge and performing activities to support the site inspection readiness and maintenance of the site compliance. This position will work with a high level of independence and actively coordinate/participate in activities 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 walk-through 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.
• Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
• Perform other duties as required by management.

Preferred Qualifications

• MBA is a plus.