● Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

● Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

● Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

● Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

● Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

● Coordinates legal requests in support of government investigations or litigations.

● Assistant with department manager for all the document control.

● Ensures the quality assurance programs and policies are maintained and modified regularly.

● Facilitates uniform standards for the site and enables best practice sharing, thereby fostering the achievement of company's mission globally.

● Work within a GMP regulated manufacturing area to provide and assist in the implementation of quality-related continuous improvement opportunities.