Site Self-Inspection & Compliance Lead

Viatris; St. Albans (VT); On-site; USD 95,000 - 193,000; Full time

Job summary

Mylan Technologies, Inc. is seeking a Site Self Inspection Lead to manage the site self-inspection program, coordinate with leadership and GOA, and oversee inspections and CAPA actions. The role emphasizes robust quality processes and readiness for audits across Viatris facilities.

The position requires a strong background in cGMP, global regulations, and quality systems, with a technical Bachelor’s degree and 10+ years in a GXP setting. Travel and collaboration across units are expected.

Qualifications

• Extensive knowledge of pharmaceutical cGMP and global regulations.
• Understanding of quality system requirements across GMP/GXP.
• Experience in applying global GMPs to improve site systems and processes.

Responsibilities

• Create and track the site self-inspection plan and agenda.
• Liaise with Site Leadership and Global Operations Auditing for alignment.
• Lead and participate in site self-inspections and record-keeping.
• Evaluate CAPA items and ensure effective actions.
• Prepare annual trend reports and share Learnings regionally.

Skills

cGMP knowledge

Regulatory compliance

Quality system knowledge

Education

Bachelor's degree in Science/Engineering

Job description

Mylan Technologies, Inc. is seeking a Site Self Inspection Lead to manage the site self-inspection program, coordinate with leadership and GOA, and oversee inspections and CAPA actions. The role emphasizes robust quality processes and readiness for audits across Viatris facilities.

The position requires a strong background in cGMP, global regulations, and quality systems, with a technical Bachelor’s degree and 10+ years in a GXP setting. Travel and collaboration across units are expected.