Lead Specialist, QA Quality Systems

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 Lead Specialist, QA Quality Systems role will make an impact:

Key responsibilities for this role include:

• Lead complex / critical investigations, trends, propose associated CAPA actions and prepare associated investigation reports.

• Represent QA in the triage of deviations, assuring appropriate initial evaluation of extent/scope and containment actions occur to minimize risk and potential product/quality impact.

• Leads / facilitates cross functional structured problem solving in support of investigations.

• Compile and analyze investigation information required for Annual Product Reviews, Management Review, Site Metrics, and other business needs, and prepare associated reports and/or presentation slides. Present to local and vertical leadership as required.

• Performs PQRs.

• Provides oversight/assessment for Potentially Critical Complaints.

• Leads periodic and special cause trending assessments to determine corrective actions to address trends.

• Compiles/Analyzes investigation system related reports to support APRs/PQRs, Management Review, and Site Metrics.

• Provides leadership and oversight for assigned elements of the Site Quality System.

• Leads continuous improvement project teams. Develops strategies and tactics for accomplishing objectives, manages tasks execution through completion.

• Approves laboratory investigations, incidents, and investigations as authorized.

• Serves as Site Contact/Back up for Global Initiatives related to improvement of Quality Systems 13. Provides mentorship and supports training/development of Quality Systems Specialist/Senior Specialist. 14. Supports external Audits (ie Corporate, Vendor, ISO etc) and Health Authority Inspections

The minimum qualifications for this role are:

• Bachelor's degree, 10 years of relevant experience in a GMP environment, and comprehensive knowledge of Quality Systems and cGMP. A combination of experience and/or education will be taken into consideration.

• Must possess a working knowledge of cGMP and Quality Systems. Must understand the cGMP standards for the change control and change implementation with basic understanding of regulatory expectations in relation to change management.

• Must possess strong communication skills (written and verbal). Must have experience in technical writing.

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.