Site Self-Inspection Lead

Mylan Teoranta At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. 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. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing The Site Self Inspection Lead is a critical role based at each manufacturing facility to 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. Every day, we rise to the challenge to make a difference and here’s how the Site Self-Inspection Lead role will make an impact:

• 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.
• Perform other duties as required by management.

About Your Skills & Experience For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Experience in Aseptic processing, sterile product manufacturing and cleanroom environment is essential.
• 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).
• Minimally Primary or Higher Degree in Science, Engineering, or related technical discipline with at least 10 years’ experience in a GXP setting, extending across a range of functions inclusive of Quality Assurance.
• 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.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles. Why Viatris? At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives. Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer.