Senior Director, Quality and Compliance

<p>TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.<br/></p><p><strong><strong>Join Our Team as a</strong></strong> <strong>Senior Director, Quality and Compliance - home based in any TFS European location.</strong></p><p><strong>About this role</strong></p><p>As part of our <strong>Quality and Compliance</strong> team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.<br/><br/>The <strong>Senior Director, Quality and Compliance </strong>is responsible for ­­­­­­­­­­­­­­­­­compliance control and inspection readiness across TFS, and will work according to company policies, SOPs, and regulatory requirements. </p><p>You will be accountable for strategy, performance/delivery, compliance and operational results of the Quality &amp; Compliance department.</p><ul> </ul><p><strong>Key Responsibilities: </strong></p><p><strong>Compliance Oversight</strong></p><ul> <li>Maintain expert-level knowledge of relevant regulations, GxP standards, and internal procedures.</li> <li>Ensure company-wide compliance through proactive monitoring, communication, and implementation of regulatory requirements.</li> <li>Lead integration of regulatory changes into the Quality Management System (QMS); oversee major quality events.</li> <li>Advise stakeholders on compliance strategies and risk mitigation.</li> <li>Define acceptable compliance thresholds in collaboration with executive leadership, monitor performance and address deviations.</li> </ul><p><strong>Leadership and Strategic Management</strong></p><ul> <li>Build and lead a high-performing efficient GCP-focused Quality &amp; Compliance (Q&amp;C) team aligned with business goals and strategy.</li> <li>Oversee quality and compliance metrics reporting.</li> <li>Ensure global procedures (e.g., SOPs) are current and compliant with ICH, GCP, and EU/US directives.</li> <li>Optimize Q&amp;C processes for efficiency and effectiveness.</li> <li>Serve as Business System and Process Owner as assigned; maintain the Quality Manual and contribute to client/sponsor Quality Agreements.</li> <li>Provide full line management for Q&amp;C staff, including recruitment, performance evaluation, training, succession planning, and administrative oversight.</li> <li>Mentor and coach team members; manage time reporting and expense tracking.</li> <li>Ensure Q&amp;C deliverables meet TFS quality standards, support whistleblowing procedures in coordination with Legal.</li> <li>Contribute to cost modelling, pre-sales activities, RFPs/RFIs, and post-award documentation (e.g., MSAs) for quality/compliance services</li> <li>Collaborate with senior leadership and cross-functional teams to foster a positive and productive work environment.</li> </ul><p><strong>Audit Management</strong></p><ul> <li>Develop and execute the Annual Audit Plan.</li> <li>Lead internal and external audit activities, including preparation, hosting, and follow-up.</li> <li>Review audit reports and provide strategic guidance to internal auditors and participating TFS staff.</li> <li>Maintain robust documentation to support compliance and business continuity.</li> </ul><p><strong>Regulatory Inspections</strong></p><ul> <li>Manage and host regulatory inspections of TFS operations, and oversee response to regulatory findings</li> <li>Coordinate preparation of investigational sites for inspection readiness.</li> <li>Support client-related regulatory inspections.</li> <li>Maintain comprehensive records to ensure inspection readiness and continuity.</li> </ul><p><strong>Quality Management System (QMS)</strong></p><ul> <li>Oversee the electronic QMS (eQMS), including controlled documents, quality issues, and CAPAs.</li> <li>Ensure proper handling of complaints, potential serious breaches, fraud, and scientific misconduct investigations in line with SOPs.</li> </ul><p><strong>Additional Responsibilities</strong></p><ul> <li>Ensure vendor qualification and oversight in accordance with internal procedures.</li> <li>Ensure Computer System Validation (CSV) activities and oversight in accordance with internal procedures</li> <li>Perform other quality and compliance-related tasks as delegated.</li> </ul><ul> </ul><p><strong>Qualifications: </strong></p><ul> <li>University/college degree in life science or equivalent </li> <li>Minimum 10 years’ experience in clinical research, (e.g. monitoring, data management, drug safety, training, etc.)</li> <li>Minimum 10 years’ experience of auditing in two to three GxP areas</li> <li>Minimum 10 years in compliance or relevant leadership role.</li> <li>Excellent knowledge of GxP regulations and guidance. Awareness of global trends, and government policies in the clinical trials area.</li> <li>Strong experience