The Quality Assurance Manager develops, initiates, and manages the plans and objectives for the Quality Assurance (QA) team, directs and develops staff, as well as ensures internal and vendor resources are effectively allocated to meet business goals.
This quality assurance management position is the focal point for all quality and safety aspects of AIT business. The QA manager will monitor and perform verification procedures including inspections of incoming, in-process and final product.
In this role, you will perform or assure quality, risk management, safety, reliability and maintainability of program achievements, subcontractors, and suppliers in accordance with contractual requirements.
In this role, the selected candidate will assist in the maintenance, development and updating of the Quality Organizations Business Systems to ensure sustained compliance to AS9100; IS09001, NADCAP and customer certifications requirements.
In this role, you will be responsible for managing UAT resources to build processes and efficient strategic test plans that will allow the team to become great assets to our sales operations organization.
In this role, you will provide leadership and direction to front line quality & production management. The selected candidate will also implement manufacturing process standards for all production facilities.
In this role, you will be to ensure quality and compliance of Halozyme - sponsored clinical trials and related systems with respect to Halozymes Standard Operating Procedures, applicable regulatory requirements ( FDA, EU, ICH & country specific ), and current industry standards and practices.