PpTFS 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 h3Join Our Team as a Senior Director, Quality and Compliance- home based in any TFS European location. /h3 h3About this role /h3 pAs part of our bQuality and Compliance /b team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals. /p pThe bSenior Director, Quality and Compliance /b is responsible for compliance control and inspection readiness across TFS, and will work according to company policies, SOPs, and regulatory requirements. /p pYou will be accountable for strategy, performance/delivery, compliance and operational results of the Quality Compliance department. /p h3Key Responsibilities: /h3 h3Compliance Oversight /h3 ul liMaintain expert-level knowledge of relevant regulations, GxP standards, and internal procedures. /li liEnsure company-wide compliance through proactive monitoring, communication, and implementation of regulatory requirements. /li liLead integration of regulatory changes into the Quality Management System (QMS); oversee major quality events. /li liAdvise stakeholders on compliance strategies and risk mitigation. /li liDefine acceptable compliance thresholds in collaboration with executive leadership, monitor performance and address deviations. /li /ul h3Leadership and Strategic Management /h3 ul liBuild and lead a high-performing efficient GCP-focused Quality Compliance (QC) team aligned with business goals and strategy. /li liOversee quality and compliance metrics reporting. /li liEnsure global procedures (e.g., SOPs) are current and compliant with ICH, GCP, and EU/US directives. /li liOptimize QC processes for efficiency and effectiveness. /li liServe as Business System and Process Owner as assigned; maintain the Quality Manual and contribute to client/sponsor Quality Agreements. /li liProvide full line management for QC staff, including recruitment, performance evaluation, training, succession planning, and administrative oversight. /li liMentor and coach team members; manage time reporting and expense tracking. /li liEnsure QC deliverables meet TFS quality standards, support whistleblowing procedures in coordination with Legal. /li liContribute to cost modelling, pre-sales activities, RFPs/RFIs, and post-award documentation (e.g., MSAs) for quality/compliance services /li liCollaborate with senior leadership and cross-functional teams to foster a positive and productive work environment. /li /ul h3Audit Management /h3 ul liDevelop and execute the Annual Audit Plan. /li liLead internal and external audit activities, including preparation, hosting, and follow-up. /li liReview audit reports and provide strategic guidance to internal auditors and participating TFS staff. /li liMaintain robust documentation to support compliance and business continuity. /li /ul h3Regulatory Inspections /h3 ul liManage and host regulatory inspections of TFS operations, and oversee response to regulatory findings /li liCoordinate preparation of investigational sites for inspection readiness. /li liSupport client-related regulatory inspections. /li liMaintain comprehensive records to ensure inspection readiness and continuity. /li /ul h3Quality Management System (QMS) /h3 ul liOversee the electronic QMS (eQMS), including controlled documents, quality issues, and CAPAs. /li liEnsure proper handling of complaints, potential serious breaches, fraud, and scientific misconduct investigations in line with SOPs. /li /ul h3Additional Responsibilities /h3 ul liEnsure vendor qualification and oversight in accordance with internal procedures. /li liEnsure Computer System Validation (CSV) activities and oversight in accordance with internal procedures /li liPerform other quality and compliance-related tasks as delegated. /li /ul h3Qualifications: /h3 ul liUniversity/college degree in life science or equivalent /li liMinimum 10 years’ experience in clinical research, (e.g. monitoring, data management, drug safety, training, etc.) /li liMinimum 10 years’ experience of auditing in two to three GxP areas /li liMinimum 10 years in compliance or relevant leadership role. /li liExcellent knowledge of GxP regulations and guidance. Awareness of global trends, and government policies in the clinical trials area. /li liStrong experience in driving the quality and compliance within CROs and their regulatory and business requirements /li liStrong leadership skills, problem-solving and team management /li liExtensive ability to deal effectively with inspectors, sponsors, and internal customers at all levels /li liWillingness and ability to travel /li liExcellent English verbal and written communication skills. /li liFluency in other languages will be considered as an advantage /li /ul h3What We Offer /h3 pWe provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients /p h3A Bit More About Us /h3 pOur journey began over 29 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. /p pOur core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. /p pbTogether we make a difference. /b /p /p #J-18808-Ljbffr