Site Self-Inspection Lead: Drive Compliance & CAPA

1100 Mylan Pharmaceuticals Inc.; St. Albans (WV); On-site; USD 95,000 - 193,000; Full time

Job summary

Viatris is seeking a Site Self-Inspection Lead in the United States to develop and manage the site self-inspection program. You will coordinate with site leadership and Global Operations Auditing to align on scope, lead inspections, and ensure robust CAPA actions are implemented.

The role requires deep knowledge of cGMP/GxP, regulatory requirements, and a senior level in QA with at least 10 years in a GXP setting. Exact compensation depends on location and experience.

Qualifications

• Extensive knowledge of pharmaceutical cGMP and global government regulations (FDA, EMA, ICH, ISO).
• Strong quality system understanding and ability to apply GMPs to site processes.

Responsibilities

• Create and track site self-inspection plans and schedules.
• Lead site self-inspections and coordinate with leadership and GOA.
• Record and communicate inspection results; follow up on CAPA actions.
• Prepare annual trend reports and identify opportunities across Viatris.

Skills

Pharma regulatory knowledge

Quality Assurance

GxP compliance

GMP expertise

Auditing

Education

Bachelor's degree in Science/Engineering

Job description

Viatris is seeking a Site Self-Inspection Lead in the United States to develop and manage the site self-inspection program. You will coordinate with site leadership and Global Operations Auditing to align on scope, lead inspections, and ensure robust CAPA actions are implemented.

The role requires deep knowledge of cGMP/GxP, regulatory requirements, and a senior level in QA with at least 10 years in a GXP setting. Exact compensation depends on location and experience.