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Third Party Quality Lead<br><p>ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.</p><br><p>As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.</p><br><p>The Third Party Quality Lead (TPQL) reports to the Head of Third Party Quality and partners with stakeholders to manage third-party quality risk, issue resolution, and GCP compliance. This role acts as the primary Quality contact for key vendors supporting Clinical Development & Operations, ensuring they maintain strong quality systems and meet all applicable regulatory GCP requirements related to patient safety, data integrity, and protocol adherence. The TPQL also supports vendor oversight, engagement frameworks, and quality processes across external partnerships.</p><p></p><p><b>What You Will Do:</b></p><ul><li><p>Identify, evaluate and respond to GCP quality risks related to vendor and site engagement</p></li><li><p>Lead quality discussions with key vendors and sites and present quality point of view at relevant oversight meetings</p></li><li><p>Provide quality oversight reports to appropriate Pfizer management / functions</p></li><li><p>Communicate key quality information (e.g., inspection / audit learnings) across vendors and site entities and serve as quality expert for third parties</p></li><li><p>Validate, monitor and close out GCP-quality-related action plans</p></li><li><p>Evaluates quality performance at an enterprise level to inform continuous improvement of quality risk management</p></li><li><p>Informs site organization relationship owner of <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">quality improvement</span> considerations</p></li><li><p>Support QMS09 BPO in the development and implementation of process updates</p></li><li><p>Support Vendor Leads / Business Owners to <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">ensure compliance</span> with functional level vendor oversight requirements</p></li></ul><p></p><p><b>Your Profile:</b></p><ul><li><p>BS--7+ years or equivalent</p></li><li><p>MS/MBA – 6+ years or equivalent</p></li><li><p>Minimum of 5 years of pharmaceutical experience with <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">solid experience</span> in clinical trial development</p></li><li><p>Robust knowledge in quality areas (i.e. audit, inspection, compliance, and inspection readiness fields)</p></li><li><p>Quality related experience including working knowledge in:</p></li><li><p>Quality and compliance management, QC</p></li><li><p>Root Cause Analysis</p></li><li><p>Risk identification, controls, mitigations, and actions</p></li><li><p>Metrics development and utilization</p></li><li><p>Audit and Inspection conduct and CAPA response process</p></li><li><p>Ability to develop strategies using coordinated and transparent metrics to track and manage compliance</p></li><li><p>Ability to participate in cross-line global initiatives or root cause analysis for quality related process improvement</p></li></ul><p></p><p></p><p></p><p><span>#LI-DG1</span></p><p><span>#LI-Remote</span></p><p></p><br><p>Employment with ICON is contingent upon having the legal right to work in the country where the role is based.</p><br><p><b>Rewards & Benefits</b></p><p>ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.</p><br><p>Benefits may include:</p><ul><li>Competitive base salary and performance related incentives</li><li>Health and wellbeing programmes including medical, dental, and vision coverage where applicable</li><li>Retirement and pension plans</li><li>Life assurance and disability coverage</li><li>Employee assistance programmes and wellbeing resources</li><li>Learning and development opportunities through structured training and career pathways</li></ul><br><p>Benefits may vary depending on role and location.</p><br><p>Visit our <a href="https://careers.iconplc.com/benefits" target="_blank" rel="noopener noreferrer">careers site</a> to read more about the benefits ICON offers.</p><br><p><b>Inclusion and Accessibility</b></p><p>ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.</p><br><p>If you require reasonable accommodations during the recruitment process, please let us know or submit a request <a href="https://careers.iconplc.com/reasonable-accommodations" target="_blank" rel="noopener noreferrer"><span style="color:#0875e1"><b><u>here</u></b></span></a>.</p><p style="text-align:inherit"></p><p style="text-align:left"><span>Are you a current ICON Employee? Please click </span><a href="https://wd3.myworkday.com/icon/d/task/1422$1235.htmld" target="_blank" rel="noopener noreferrer">here</a><span> to apply</span></p>
