Provide Quality leadership and oversight to batch record review team and related activities. Perform and lead Product Disposition, encompassing the review of production batch records and associated documentation required to release a production lot, as required. This individual manages the batch documentation package and maintains records. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. Willing to be proactive and to provide effective long-term solutions non-conformances observed.