Working through individual contributors or supervisors, ensures the effective implementation and maintenance for Quality Systems requirements including but not limited to, MDD 93/42/EEC, ISO13485, CMDR, and QSRs. Ensures organizational compliance with Quality Systems procedures and regulations.
In this role, you will verify all construction subcontractors and vendors adherence to specifications, drawings and other guidelines.
Interact with owner, agencies, subcontractors and internal departments on inspection and quality related matters.
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.
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.
The Quality Assurance Manager is responsible for planning and directing quality assurance policies, programs, and initiatives for a contract. This position is responsible for the implementation of quality assurance procedures to ensure compliance with all legal, environmental and health and safety parameters.