.Job Description Our 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 is 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.
This includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE, ensuring they are 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 the 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 in 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, applying risk-based approaches and driving 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.
Establish clear expectations, measures, and periodic monitoring of operational and quality performance associated with External Manufacturing.
Provide leadership for oversight of quality due diligence assessments for pre-approval considerations of new external providers.
Provide leadership and strategy to ensure the establishment and maintenance of Quality Agreements.
Direct and manage major External Manufacturing Quality investigations, ensuring that Significant Investigations and Fact Findings are organized appropriately and coordinate any recalls as appropriate.
Participate as a member of an EQA Platform / Regional Leadership Team and other committees as appropriate.
Exhibit our company Leadership Behaviors and provide 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 is required.
Prior people management experience is preferred.
Ability to travel 25%, occasionally on short notice