Senior Scientist, 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>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>Do you enjoy working cross functional and have exposure to all –levels internal clients? Our Quality Systems (QS) team is looking for a new colleague. If you like continuous development and growth AGC Biologics is the place to be.</b></p><p></p><p>Do you have a compliance systems background and want to be responsible for the maintenance of the quality systems, Quality Risk Management oversight, and data trending of QMS processes?  Do you enjoy collaborating with internal and global partners, preparing, and providing guidance on execution of the processes referenced? Additionally, do you have experience as project lead of optimizing of quality systems and quality processes? This may be just the role for you! Our QS team is looking for a diligent and customer-oriented Senior Scientist to join our team in Copenhagen. </p><p></p><p><b>The QS department</b></p><p>QS is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, all with several years of experience in quality assurance. The QS team is responsible for maintenance and development of our quality systems for etc. Quality Management Review, Deviation, CAPA, Change Management, Complaints, Training Management, and Document Control. We also have oversight of the Supplier Qualification program, internal and external audits, and regulatory inspections. The team works closely together with the Quality Operations team, and routinely collaborates with partners across all functional areas at the site and globally, 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 – and to our customers.</p><p></p><p><b>The role:</b></p><p>As a QS Senior Scientist, you will be responsible for the maintenance of the quality systems, performing Quality Risk Management oversight, supporting and handling complaints and recall and other relevant QMS processes.</p><p>The role collaborates actively, with internal customers from all GMP areas across the site and with our Global sites and our corporate quality organization.</p><p></p><p><b>Your profile:</b></p><ul><li>Master’s degree or PhD in Natural Science.</li><li>5+ years of experience in a similar industry and a strong working knowledge of GMP.</li><li>A strong familiarity with regulatory requirements from FDA, DMA, EMA, and/or other regulatory agencies.</li><li>Experience with Quality Risk Management, complaint and recall handling, and other QMS processes.</li><li>Strong skills in writing procedures and SOPs.</li><li>Strong written and verbal communication skills and professional communication in English, which is our company language.</li><li>Strong decision making and ‘can do’ attitude.</li><li>Ability to actively develop and maintain strong professional relationships, building trust and respect across the organization</li><li>Ability to lead through influence, effectively build alignment, and collaborate with multiple stakeholders.</li><li>Ability to facilitate organizational change related to quality systems across multiple functions.</li><li>Lean experiences is preferable.</li></ul><p></p><p>We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the ad will close. We are therefore looking forward to receiving your application today! For further information regarding the position, please contact Manager in QS, Hanh Tuyet Dinh, <a href="mailto:htdinh@agcbio.com" rel="noopener noreferrer" target="_blank">htdinh@agcbio.com</a>.</p><p></p><p><b>Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. <br/> </b></p><p><b>AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with