Site Self Inspection Lead, Quality Assurance – 1st shift

Mylan Technologies, Inc. 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. Every day, we rise to the challenge to make a difference and here’s how the Site Self Inspection Lead will make an impact: Key responsibilities for this role include: 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. The minimum qualifications for this role are: Must possess extensive knowledge and 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. Minimum of a Bachelor's 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. However, a combination of experience and/or education will be taken into consideration. Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000 - $193,000. 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. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.

Salary : $95,000 - $193,000