Description

Own the site quality management system, ensuring regulatory compliance and operational excellence.

This role is on-site.

Responsibilities

• Develop and maintain quality system processes, including metrics reporting, tracking, and trending for FDA and management reviews.
• Manage the full lifecycle of CAPA initiation, review, surveillance, and reporting.
• Facilitate site Quality Management reviews and lead the Change Management process.
• Lead root cause analyses through cross-functional collaboration.
• Coordinate and provide direct support for internal and external facility audits.

Required Skills

• 5+ years of experience in Quality Management within a regulated environment.
• Deep understanding of Good Documentation Practices (GDP) and regulatory requirements.
• Proven ability to manage CAPA, Change Management, and Root Cause Analysis.
• Experience leading Quality on the Floor initiatives and personnel.
• Strong skills in data collection, reporting, and trending analysis.
• Bachelor's degree in a relevant scientific or engineering discipline.

Preferred Skills

• Experience interpreting and applying FDA regulatory requirements.
• Background in managing product recall data collection and reporting.

Key Skills

Education

Bachelor's degree