Senior Scientist, Inspection & Audit Team, Quality Systems

<p><b>Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.</b></p><p></p><p><b><span>Our Quality Systems department is looking for a highly motivated and experienced Senior Scientist with strong expertise in Internal Auditing to join our Inspection &amp; Audit team.</span></b></p><p></p><p><b><span>About the Role:</span></b></p><p><span>As Senior Scientist in the Inspection &amp; Audit team, you will serve as the primary Internal Auditor, leading and executing our internal audit program while supporting other activities. This role focuses on developing and implementing internal audit strategies to ensure GMP compliance across our operations. You will work with a team of scientists also responsible for management of regulatory inspections, customer audits, and Quality Assurance Agreements (QAAs) with external customers.  This role requires deep knowledge of GMP regulations, strong attention to detail, organization, and is comfortable interacting cross-functionally with internal and external stakeholders.</span></p><p><span> </span></p><p></p><p><b><span>About the Quality Systems department:</span></b></p><p><span>The Inspection &amp; Audit team is part of the Quality Systems department and is an integral part of the Quality organization at AGC Biologics. You will be joining a diverse team of highly qualified colleagues, all with several years of experience within quality assurance. We are actively involved in the constant development and improvement of the quality system and our facility in Søborg and have a close collaboration with our global AGC sites. The team collaborates with partners across all functional areas at the site, to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with cGMP. We keep an open communication with focus on a high level of professionalism. We are open-minded and committed to providing high-quality service to our colleagues in the rest of AGC Biologics– and to our customers, as well.</span></p><p><span> </span></p><p></p><p><b><span>Responsibilities:</span></b></p><ul><li><p><b><span>Internal Audits:</span></b></p></li></ul><p><span><span>o<span><span> </span></span></span></span><span>Lead the development and execution of the site's internal GMP audit program</span></p><p><span><span>o<span><span> </span></span></span></span><span>Plan and conduct risk-based internal audits across all GMP-regulated operations</span></p><p><span><span>o<span><span> </span></span></span></span><span>Author detailed audit reports and track completion of corrective actions</span></p><p><span><span>o<span><span> </span></span></span></span><span>Train and mentor other team members on audit techniques</span></p><p><span><span>o<span><span> </span></span></span></span><span>Drive continuous improvement through audit findings and trends analysis</span></p><p><span><span>o<span><span> </span></span></span></span><span>Ensure internal audit program meets regulatory requirements and industry best practices</span></p><ul><li><p><b><span>Quality &amp; Compliance:</span></b></p></li></ul><p><span><span>o<span><span> </span></span></span></span><span>Develop and maintain robust internal audit procedures aligned with GMP requirements</span></p><p><span><span>o<span><span> </span></span></span></span><span>Drive collaboration across site functions to remediate top compliance risks</span></p><p><span><span>o<span><span> </span></span></span></span><span>Support quality system improvements based on audit findings</span></p><p><span><span>o<span><span> </span></span></span></span><span>Support the development of inspection and audit programs that ensure continuous compliance with applicable regulations and quality standards.</span></p><p><span><span>o<span><span> </span></span></span></span><span>Participate in management reviews of quality metrics and trends.</span></p><ul><li><p><b><span>Regulatory Inspections:</span></b></p></li></ul><p><span><span>o<span><span> </span></span></span></span><span>Assist in the preparing the organization for regulatory inspections (e.g. DMA, FDA, ANVISA, etc.) ensuring compliance with applicable regulations and standards.</span></p><p><span><span>o<span><span> </span></span></span></span><span>Assist with implementing key inspectional processes such as compliance risk assessment, presenter preparation, logistical infrastructure, inspection staff training program and talent management program for inspection speakers &amp; logistical support staff.</span></p><p><span><span>o<span><span> </span></span></span></span><span>Contribute to inspection readiness activities.</span></p><ul><li><p><b><span>Customer Audits:</span></b></p></li></ul><p><span><span>o<span><span> </span></span></span></span><span>Manage all a