In this role, the selected candidate will be experiencing in training others in QMS and continuous improvement principles and tool use including: internal audit, root cause analysis as well as corrective and preventive process improvement.
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.
The Quality Manager handles Customer quality issues to include Customer Returns (RMAs), Customer Corrective Actions (SCARs), Customer Complaints as they relate to the quality of the parts and paperwork, and works with all levels in the organization to implement improvements to improve overall Quality Results.
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 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.
In this role, you will be responsible for monitoring preventive maintenance processes and identifying opportunities for improvement and determine possible solutions / actions to address any identified deficiencies.
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 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.