Senior QA Systems Lead: Investigations & CAPA

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

Job summary

Mylan Technologies, Inc. is seeking an experienced QA leader to drive complex investigations, manage CAPA actions, and ensure excellence in a GMP environment.

The role emphasizes QA triage of deviations, cross-functional problem solving, and reporting for site metrics and management reviews. The successful candidate will guide investigation processes, oversee the Site Quality System, mentor staff, and support external audits and Health Authority inspections.

Qualifications

• BS degree and 10+ years of experience in a GMP environment.
• Working knowledge of cGMP and Quality Systems.
• Understanding of change control and regulatory expectations related to change management.
• Strong communication and technical writing skills.

Responsibilities

• Lead complex investigations, identify trends and propose CAPA actions.
• Represent QA in deviation triage and containment actions to minimize risk.
• Facilitate cross-functional problem solving for investigations.
• Compile and analyze information for APRs, Management Reviews, and site metrics; present findings.
• Perform PQRs and oversee Potentially Critical Complaints.
• Lead trending assessments to determine corrective actions.
• Provide leadership for Site Quality System elements and training for staff.
• Support external audits and Health Authority inspections.

Skills

Lead investigations

CAPA actions

Cross-functional collaboration

Statistical analysis

Technical writing

Effective communication

Presentation/reporting

Mentorship

Quality systems oversight

Problem solving

Education

BS degree

Job description

Mylan Technologies, Inc. is seeking an experienced QA leader to drive complex investigations, manage CAPA actions, and ensure excellence in a GMP environment.

The role emphasizes QA triage of deviations, cross-functional problem solving, and reporting for site metrics and management reviews. The successful candidate will guide investigation processes, oversee the Site Quality System, mentor staff, and support external audits and Health Authority inspections.