Senior QA Operations Lead - GMP & Process Improvement

Viatris Inc.; Vermont; On-site; USD 55,000 - 105,000; Full time

Job summary

Viatris Inc. is a global healthcare company dedicated to bridging generics and brands to improve worldwide access to medicines. The Senior Specialist, QA Operations will review batch records, release materials and ensure GMP compliance across manufacturing processes.

The role also involves leading investigations of deviations, driving quality system improvements, and developing SOPs and training modules to support continuous QA operations.

Qualifications

• Bachelor’s degree; 4+ years of experience in a GMP environment.
• Solid understanding of quality systems (cGMP, ICH, ISO) and Pharmacopoeia basics.
• Proficient with standard software packages (MS Word, MS Excel, MS Access, MS Project).

Responsibilities

• Review in-process batch records, finished product batch records (Pharm. and/or MPD), and intermediate analytical records.
• Release intermediate materials and assess manufacturing documentation for GMP compliance.
• Lead evaluations of deviations and events; participate in investigations as required; drive continuous improvement of the quality system.
• Develop and maintain SOPs, QFs and training modules; conduct QA training activities.

Skills

Quality Systems

GMP knowledge

Computer literacy

Education

Bachelor’s degree

Tools

MS Word

MS Excel

MS Access

MS Project

Job description

Viatris Inc. is a global healthcare company dedicated to bridging generics and brands to improve worldwide access to medicines. The Senior Specialist, QA Operations will review batch records, release materials and ensure GMP compliance across manufacturing processes.

The role also involves leading investigations of deviations, driving quality system improvements, and developing SOPs and training modules to support continuous QA operations.