.Job DescriptionOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.We are currently seeking an Associate Director External Quality who is accountable for activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.The incumbent is also a subject matter expert for both EQA and manufacturing division in specific Quality Systems, technology platforms, regulatory expectations and/or external entity management. The incumbent may also serve as the representative of our company in outside forums on their area of expertise, driving complex cross-functional initiatives to develop/optimize Quality/business processes applying risk-based approaches and driving continuous improvement activities at the external entity.Primary activities include, but are not limited to:Accountable for all aspects of end-to-end External Entity performance, and serve as the primary contact for the relationship, apply risk-based approaches and drive continuous improvement activities.Provide leadership and direction to help execute a risk-based system for calibrated quality oversight based on the product type as well as the capabilities and quality performance of an external manufacturer.Establishes clear expectations, measures and periodic monitoring of operational and quality performance associated with External Manufacturing. Provides leadership for oversight of quality due diligence assessments for pre-approval considerations of new external providers.Provides leadership and strategy to ensure the establishment and maintenance of Quality Agreements.Direct and manage major External Manufacturing Quality investigations, ensure that Significant Investigations and Fact Findings are organized appropriately and co-ordinate any recalls as appropriate.Participate as a member of an EQA Platform / Regional Leadership Team and other committees as appropriate.Exhibits our company Leadership Behaviors and provides a leadership example for the team.Works strategically and in collaboration with other functions to continuously improve our company's effectiveness and efficiency in quality management and quality systems supporting the external network.Moderate level of contractual and financial awareness.Prior people management experience preferred.Ability to travel 25%, occasionally on short notice