• Work with subject matter experts to keep the site inspection-ready, organizing resources and materials, and provide input on correspondences with the regulatory authorities.
• Lead internal audits for the site's compliance to GMP regulations
• Establish and renew Quality Agreements with suppliers, monitor supplier audit results/responses, and on occasion, participate in audits of suppliers.
• Manage the cross-contamination risk assessment process, evaluating the risk of change requests to the site's product portfolio and facilities.
• Write and peer-review investigations, risk assessments, and root cause analysis related to product post-market surveillance and complaints.
• Participate in monthly and quarterly routines for the site's compliance, including the site's quality council, annual product reviews and related sub-reports, and various trending reports.