AstraZeneca Pharmaceuticals LP Quality Supply Manager in Coppell, Texas
Responsible for Quality Assurance activities that directly support execution of Quality Management of Suppliers both within the Process Execution Team (PET) and assigned areas for Global External Sourcing Suppliers of Formulated & Packed Product, Active Pharmaceutical Ingredient, and Global Direct Materials. This includes: Quality System oversight and/or performance of: audits, change control, product quality complaint and deviation investigations, issue management and escalation, product release, Agreements (establishment and maintenance) between AstraZeneca and External Suppliers and between Global External Sourcing and AstraZeneca Operations Sites. The preparation and submission of Supplier Quality Assessments, Regulatory Agency interactions (prep and management of inspections at external suppliers and AstraZeneca sites when external suppliers are assessed) and serving as Quality Assurance leaders on new product Introductions, new supplier introductions and In Licensing & product transfer projects. Will be a Qualified Person. Alternatively the incumbent is the Quality Assurance leader for the management and support of Quality Systems within Global External Sourcing, across all Process Centric Organizations/Process Execution Teams and Categories/Sub Categories.