**Description**

To ensure that the quality system's design, implementation and execution are compliant with applicable validation and cGMP regulations across the site. Provide key support to the Site Leadership Team for all validation requirements. Assist the site in key compliance activities and responsibilities, as described below. Be a source of expertise for the site in understanding validation and cGMP regulations, implementing them in a practical way, maintaining and improving compliance and facilitating successful site audits by Regulatory Agencies.

+ Assist GMP site director in developing and implementing validation processes across the full scope of manufacturing operations and building systems. (60%)
+ Provide oversight to site functional teams to ensure they maintain compliance with all documented validation policies and procedures within the plant. Specifically but not limited to: IQ, OQ, PQ, and PPQ validation, change control, and open deviations. Ensu...