Manager, Quality Investigations

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 Manager Quality Investigsations role will make an impact:

Key responsibilities for this role include:

• Provide tactical leadership to the Quality Investigations group.

• Responsible for the management of the process for investigations of deviations, non-conformances and significant quality events within TrackWise at MTI. a. Assure timely investigations and works cross-functionally to ensure that investigation deadlines are met. b. Organize and lead cross functional investigation teams, as required. c. Collaborates with the Quality Assurance Operations Department, Manufacturing Department, and with other internal departments to establish effective CAPA in response to deviations, non-conformances and significant quality events. d. Prepare reports, data and presentations as required for Management Review, Site Metrics and other business needs.

• Perform Quality Assurance Final Approval of Investigations and CAPA within TrackWise.

• Manage external audits of the Pharmaceutical Division by customers, Viatris Global, and Health Authorities as required.

• Support Global Quality Investigation requirements and initiatives, as necessary.

• Manage the Investigations team by communication job expectations; planning, monitoring, and appraising job results; coaching employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.

• Participate in the development, maintenance and continuous improvement of quality assurance system related to the management of investigations. Assure that department SOPs comply with cGMPs and conform to current practice. Revise and author standard operating procedures, as needed.

• Participate in the evaluation and improvement of other Quality Systems, as required, providing leadership and guidance for implementation of new systems and system improvements, as indicated.

• Function as site SME and maintain TrackWise Investigation system and collaborate with QA Management ad Global Quality IT to assure that systems are maintained to support site needs.

• Assist in preparation of documentation prior to and during regulatory agency internal audits. Provide support in closing out observations from audits.

The minimum qualifications for this role are:

• Bachelor of Science Degree and 7+ years of relevant experience and 3+ years of leadership experience is required. Alternately a Master of Science Degree and a minimum of four years of experience is required. However, a combination of experience and/or education will be taken into consideration.

• Must be articulate in both written and oral communications including diplomatic discussion of required corrective actions with business partners. Ability to multi-task a large number of projects and evaluate priorities with minimal supervision. Maintain working relationships with individuals within Mylan Technologies as well as the global Mylan organization to ensure smooth and timely achievement of assigned goals. Must be familiar with computers and various software such as MS Word, MS Excel, MS Access and MS PowerPoint. Experience with TrackWise is desirable.

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.