Senior QA Manager, Pharmacovigilance

<span><span><span><span><span><span><span><p><b>Title:</b></p></span></span></span></span></span></span></span>Senior QA Manager, Pharmacovigilance<p></p><span><span><span><span><span><span><span><p><b>Company:</b></p></span></span></span></span></span></span></span>Ipsen Innovation (SAS)<p><br/> </p><p><b>About Ipsen:</b></p><p>Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.</p><p> Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!</p><p>For more information, visit us at <b><a href="http://www.ipsen.com/" rel="noopener noreferrer" target="_blank"><span>https://www.ipsen.com/</span></a><a href="http://www.ipsen.com/" rel="noopener noreferrer" target="_blank"> </a></b>and follow our latest news on <b><a href="http://www.linkedin.com/company/ipsen/" rel="noopener noreferrer" target="_blank">LinkedIn</a> </b>and <b><a href="http://www.instagram.com/ipsengroup/" rel="noopener noreferrer" target="_blank">Instagram</a></b>.</p><p></p><span><span><span><span><span><span><span><p><b>Job Description:</b></p></span></span></span></span></span></span></span><p><b>The Senior QA Manager, Pharmacovigilance (PV)</b>, is responsible for maintaining, developing, and monitoring the PV quality system to ensure compliance with regulatory requirements and internal standards. This role acts as the primary point of contact for Global Patient Safety (GPS)/PV functions regarding PV quality system management and supports cross-functional processes impacting PV quality system, including regulatory affairs, clinical and medical affairs, affiliates, etc. The position also contributes to promoting a Quality culture of continuous improvement.  </p><p></p><p>The ideal candidate should have a deep knowledge of GVP regulatory requirements and industry standards. Additionally, they need considerable experience in pharmacovigilance, expertise in developing and executing Quality Management Systems, and familiarity with health authorities inspections and audits tied to pharmacovigilance.</p><p></p><p><b>Main responsibilities:</b></p><p><b>Quality Documents Management</b></p><ul><li><p>Acts as QA representative for GPS regarding Quality Documents Management.</p></li><li><p>Ensures the maintenance of PV Quality Documents System by supporting their creation and update as per quality documents life cycle management.</p></li></ul><p></p><p><b>PSMF Maintenance</b></p><ul><li><p>Manages timely update of the PSMF body and annexes listing quality documents, deviations audits findings, and CAPA updates</p></li></ul><p></p><p><b>Deviation and CAPA Management</b></p><ul><li><p>Accountable for overall oversight on deviations and CAPA Plans related to or impacting the Ipsen PV system.</p></li><li><p>Ensures continuous overview and monitoring of CAPA implementation by tracking progress, providing reporting, and escalating as needed</p></li><li><p>Manages the QA review of PV deviations and consistency of CAPA Plans, across the organization at global and local level</p></li></ul><p></p><p><b>Audits and Inspections</b></p><ul><li><p>Coordinates the preparation and hosting of pharmacovigilance external audits and inspections.</p></li><li><p>Supports any <span>pre-audit/pre-inspection</span> request management.</p></li><li><p>Acts as primary contact for requests PV Quality Management System and provides responses when observations are related to the PV Quality System</p></li><li><p>Coordinates post- audit and post-inspection activities</p></li></ul><p></p><p><b>Additional duties</b></p><ul><li><p>Implements and tracks compliance KPIs related to QMS.</p></li><li><p>Provides quality updates for EU QPPV oversight.</p></li><li><p>Develops and delivers PV QMS training.</p></li><li><p>Supports affiliates with guidances on PV QMS.</p></li><li><p>Support periodic review of PV QMS</p></li><li><p>Acts as the Subject Matter Expert within Global Quality and contributes to Quality objectives</p></li></ul><p></p><p><b>To be considered for this role, you will have:</b></p><ul><li><p>Extensive experience in pharmacovigilance, including expertise in pharmacovigilance quality management and PV compliance management.</p></li><li><p>Cross-functional working skills</p></li><li><p>Good communication skills: oral-written</p></li><li><p>Result oriented – drives execution a