Based on corporate policies, develop strategy of QMS and establish quality procedures to support clinical and commercial GMP production at New Jersey site. Participate the recruitment of Quality Assurance team, retain and develop talents, and provide leadership for a high performing team to meet GMP compliance requirements and overall business objectives.Provide cross-site quality leadership to quality systems lifecycle maintenance, raw material and final product release, supply chain, automation, manufacturing, validation and facility engineering.  Apply Quality by Design principles to define a robust, integrated control strategies of the plasmid DNA platform manufacturing process.Oversee and manage the execution of quality systems during daily production activities to ensure the delivery of high quality products. Lead the preparation and execution of regulatory and client inspections, host audits and responsible for corrective action plans.Present updates to project or upper management teams on progress and enforcement of quality improvement and manufacturing support activities.Review and approve technical protocols, reports and risk assessments, and work to improve application and standardization of phase appropriate processes and curricula.Up to 10% traveling to support CDMO projects or business development activities.