Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers we create an interdependent global manufacturing network dedicated to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. We are seeking a growth and improvement-minded External Quality Associate Director that can help drive our Strategic Operating Priorities in Europe and APAC regions. Key Responsibilities Provides Quality oversight over one or more External Entities or projects that will manufacture or test cell banks, biologic drug intermediates, biologic drug substances, or biologic drug products or both on behalf of our Company for product and analytical technology transfer. Serve as the quality project lead for Technology Transfer, New Product Introduction, and Analytical Transfers to Contract Manufacturing and testing sites. 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. Works with a team of quality project leads and cross-functional transfer teams. Reports to the Quality Director, EQA, for general advice and instruction concerning Quality Operations, but functions independently. Education Bachelor's or Master's degree in a Science, Engineering, or related area of study. Required Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect. Seven years or greater relevant pharmaceutical or biotechnology industry experience with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Control. Solid knowledge of global GMP and regulatory requirements. Proficient in analyzing complex product, production, and testing issues and have demonstrated scientific problem-solving capabilities. Experience with supporting regulatory inspections. Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships. Based in Europe or APAC. Preferred Biologic and/or vaccine Quality Assurance and Quality Control. Contract Manufacturing Oversight (CMOs, Labs, etc.). Experience working in a regulated environment and with new product introductions/product transfers. IPI, QSAT, and SAP for deviation and CAPA management experience preferred. 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's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
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