Quality Systems Lead – Investigations, CAPA & Compliance

1100 Mylan Pharmaceuticals Inc.; St. Albans (WV); On-site; USD 66,000 - 127,000; Full time

Job summary

Viatris is seeking a Manager, Quality Systems to lead investigations, CAPA actions, and cross-functional problem solving in a fast-paced GMP environment. The role involves reporting on APRs/MRs, site metrics, and leading improvement projects across the quality system. Strong communication, technical writing, and extensive cGMP experience are essential.

Exact compensation varies by skills and location. Viatris is an Equal Opportunity Employer committed to diversity and inclusion.

Qualifications

• BS degree with 10+ years of GMP experience
• Working knowledge of cGMP and change control
• Ability to perform statistical analysis and calculations
• Strong written and verbal communication

Responsibilities

• Lead complex/critical investigations, trends and CAPA actions, and prepare reports.
• Represent QA in deviation triage and containment decisions.
• Lead cross-functional problem solving in investigations.
• Compile/analyze investigation data for APRs, MR, site metrics and reports.
• Present findings to local and vertical leadership as required.
• Perform PQRs and oversight for potentially critical complaints.
• Lead trending assessments to identify corrective actions.
• Analyze investigation system reports to support APRs/PQRs and site metrics.
• Provide leadership for Site Quality System elements.
• Lead continuous improvement project teams and strategic initiatives.
• Develop strategies and manage task execution to completion.
• Approve laboratory investigations and incidents as authorized.
• Serve as Site Contact for Global Quality System initiatives.
• Mentor/train Quality Systems staff.

Skills

GMP experience

cGMP knowledge

Statistical analysis

Technical writing

Strong communication

Education

BS degree

Job description

Viatris is seeking a Manager, Quality Systems to lead investigations, CAPA actions, and cross-functional problem solving in a fast-paced GMP environment. The role involves reporting on APRs/MRs, site metrics, and leading improvement projects across the quality system. Strong communication, technical writing, and extensive cGMP experience are essential.

Exact compensation varies by skills and location. Viatris is an Equal Opportunity Employer committed to diversity and inclusion.