Description:

This position will provide management oversight and leadership for core facility compliance functions. Responsible for independent Internal Manufacturing and Laboratory Investigations (both Planned and Unplanned), Customer Complaint Investigations, CAPA program, Customer Complaint Investigations, Focused Internal Audits to evaluate potential compliance risks and take appropriate mitigation efforts and also alert senior management on potential issues.

Essential Functions:

Responsible for independent Internal Manufacturing and Laboratory Investigations (both Planned and Unplanned). Responsible for Customer Complaint Investigations Responsible for Focused Internal Audits across all departments. Perform risk assessment for compliance and recommend corrective measures and preventative measures to mitigate potential compliance risks. Inform Senior Management of any activities/issues/decisions that may impact the compliance of the sites that may lead to regulatory action. Responsible for the CAPA Program Assist in the review of SOPs and other relevant documents where necessary. Participate in other compliance related projects as assigned by management.