Senior Associate, Systems Support

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.

Provide support for managing validation activities related to implementation and maintenance of Viatris’ Regulatory systems.

Perform formal test executions to support validation efforts across the Global Regulatory portfolio of systems.

Assist in maintaining consistent processes across Global Regulatory Operations for Computer Systems Validation (CSV) including support with requirements, test scripts, change controls, etc.

Partner with IT QA to ensure timelines are met and all required documentation is complete.

Collaborate with Global Regulatory System Support, Global Regulatory Operations business owners and Regulatory SMEs during validation projects to support CSV activities.

Stay current with the IT documentation required for validation activities, including the roles and responsibilities of Regulatory personnel within those deliverables in order to provide project support.

Assist with the creation of user guides to support the validation process including managing defects, testing (test script execution) tips and MTC navigation.

Partner with IT Quality Assurance to reinforce best practices and maintain consistency of validation requirements and expectations.

Contribute to the development of Standard Operating Procedures (SOPs) consistent with industry best practices.

Participate in key IT and cross-functional initiatives such as new systems, system enhancements, integration activities, etc.

Provide support to develop and maintain a consistent process with requesting, verifying, and implementing access to Global Regulatory systems.

Work with the Global Regulatory Operations Learning and Development team to provide timely access to Global Regulatory systems.

Bachelor’s degree (or equivalent) and a minimum of 1-2 years of pharmaceutical industry experience in Regulatory Operations, Information Technology, or a related area. A combination of experience and/or education will be taken into consideration. Experience with IT Computer System Validation processes in a regulated environment is strongly preferred.

Must possess ability to multi-task and manage multiple projects and deadlines. Ability to understand complex IT tools and software. Ability to read and interpret complex business and/or technical documents. Ability to work in a highly cross functional team environment. Must possess excellent attention to detail and propensity to learn. Must be proficient in Microsoft Word and Excel.

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 and communicate ambiguous concepts. Ability to present to groups across the organization.

Ability to perform computations such as percentages, ratios, and rates.

Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

Proficiency in speaking, comprehending, reading and writing English is required.