Associate Director- Quality Leader, External Site

Job Description

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The External Site Quality Leader (ESQL) is accountable for providing Quality Oversight over one or more External Entities that manufactures or tests cell banks, biologic drug intermediates, biologic drug substances, or biologic drug products or both on behalf of our Company's Manufacturing Division. Activities include the broadest possible involvement in every aspect of manufacturing and testing operations related to the quality and compliance of products produced.

• Accountable for oversight of an External Entity (EE) involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
• Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight | Components may include review of batch documentation and deviation investigations.
• Assist in managing the end-to-end processes of transfers including but not limited to: Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness and Quality System Oversight Implementation.
• Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews | Includes building effective quality systems at the EE and continuous improvement activities.
• Exhibits our company Leadership Behaviors and provides a leadership example for the team.
• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
• Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.
• Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.

This position reports to the Quality Operations Director, Large Molecule Drug Product, for general advice and instruction concerning Quality Operations, but functions independently, and provides guidance as needed to team members in the Product Quality Manager role.

Education Minimum Requirement and Experience:

• Bachelor of Science degree (BS) in a Science, Engineering, or related area of study with seven (7) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements; OR
• Master of Science degree (MS) in a Science, Engineering, or related area of study with five (5) years relevant experience in the pharmaceutical industry and/or biotechnology industry …