Capa Manager

**Responsibilities**:
- Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Main responsibilities will include, but are not limited to:
- Act as process and system SME for the nonconformance and CAPA process and business/system requirements
- Coach the Investigation Owner in understanding their end-to-end accountability of the entire CAPA process
- Develop and maintain proficiency in the TrackWise ETS QEM system
- Work with the organization to identify resources to support RCA investigations and resulting actions
- Provide assistance to the record owner to ensure process requirements are met
- Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance
- Act as a liaison between the record owner and the quality leader; the record owne...