Purpose:

Serves as the Business Technology Solutions (BTS) Subject Matter Expert for the CAPA Quality System. Performs and approves root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for IT Systems. Manages GxP audit support activities for the BTS Governance, Risk, and Compliance (GRC) organization.

Responsibilities:

• Provides consistent and thorough exception documents and timely resolution of investigations based on
• CAPA requirements
• Coordinates the exception document process
• Promotes culture of continuous improvement by identifying problems, conducting root cause analysis, and confirming appropriate implementation of corrections, corrective and preventive actions
• Independently leads complex, cross functional, high impact investigations
• Effectively collaborates/partners with other organizations within Business Technology Solutions (BTS)
• Manages GxP audit support activities for the BTS Governance, Risk, and Compliance (GRC) organization
• Establishes KPIs and monitoring processes for both the CAPA and GxP Audit support processes
• Ensures all Quality CAPA and Audit support goals and metrics are met and communicates relevant data to internal stakeholders
• Leads team members and/or project teams, including job mentoring or coaching with possibility of direct supervision responsibilities

• Bachelors degree in a technical field (Biology, Chemistry, Engineering, Computer Science, etc)
• 7+ years of experience in the pharmaceutical or medical device industries
• Minimum 2+ years writing and/or approving CAPA documents
• Minimum 2+ years directly supporting GxP audits
• Demonstrates ability to problem solve and utilize analytical skills