Senior QA Systems Lead – Quality & Compliance

Viatris; St. Albans (VT); On-site; USD 66,000 - 127,000; Full time

Job summary

Viatris is seeking a Manager, Quality Systems in Vermont to drive complex investigations, CAPA actions and compliant change control within cGMP frameworks. You will lead cross-functional teams, analyze investigation data, and prepare APRs/PQRs with senior leadership presentations.

The role emphasizes mentorship of Quality Systems staff, support for external audits, and ongoing site quality system leadership, with compensation reflecting experience and location.

Qualifications

• BS degree and 10+ years in a GMP environment with knowledge of Quality Systems and cGMP.
• Working knowledge of cGMP and quality systems; change control and regulatory expectations.
• Strong math skills and statistical analysis.

Responsibilities

• Lead complex investigations, trends, propose CAPA actions and prepare investigation reports.
• Represent QA in deviations triage with containment actions to minimize risk.
• Lead cross-functional structured problem solving in investigations.
• Prepare reports/slides for APRs, MMR, Site Metrics and present to leadership.
• Provide oversight for Potentially Critical Complaints and CAPA trending.
• Mentor Quality Systems staff and support external audits and health authority inspections.

Skills

Quality Systems

cGMP

Statistical Analysis

Technical Writing

Communication skills

Education

BS degree

Job description

Viatris is seeking a Manager, Quality Systems in Vermont to drive complex investigations, CAPA actions and compliant change control within cGMP frameworks. You will lead cross-functional teams, analyze investigation data, and prepare APRs/PQRs with senior leadership presentations.

The role emphasizes mentorship of Quality Systems staff, support for external audits, and ongoing site quality system leadership, with compensation reflecting experience and location.