Job Description :

Develop and maintain quality system processes, including metrics reporting and tracking

Manage CAPA initiation, review, surveillance, and reporting

Facilitate the site Quality Management reviews

Facilitate and lead the site Change Management process

Support and lead root cause analyses through cross functional team involvement

Leading Good Documentation Practice training and Quality on the Floor coordination and performance

Interpret and properly apply all applicable regulatory requirements

Coordinate and provide direct support for facility audits by internal and external entities

Manage data collection and reporting when product recalls are required

Perform trending of Quality Systems to support FDA and Management reviews

Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements

Review and approval of procedures, protocols, reports, etc., as required.

Department specific/Non-essential responsibilities:

Filing and management of documentation when required

Supporting other Quality System Functions

This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need