TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions. Join our team as an Associate Director / Senior Manager, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland, or home-based in Sweden, Italy, or Portugal. About this role As part of our Quality and Compliance team, you will work alongside passionate professionals to ensure our customers achieve their goals. The Associate Director / Senior Manager, Quality Assurance (GCP Auditor) is responsible for overseeing GCP activities related to clinical trials. This role involves performing daily clinical quality operations and compliance activities to support successful clinical trial projects. The primary focus is ensuring that clinical processes comply with regulatory requirements, ICH Guidelines (e.g., ICH E6 GCP), SOPs, country-specific regulations, industry standards, and practices. This role includes facilitating the creation and revision of controlled documents (e.g., Policies, SOPs), supporting risk assessments, root cause analyses, CAPA plans for quality issues, and driving quality assessments in proposals and RFIs. It also involves supporting GxP computer system validation, preparing for audits, conducting internal and external audits, hosting external audits, and ensuring inspection readiness. The ideal candidate has clinical research and quality assurance experience and can provide support and advice in this area. Key Responsibilities AUDIT: Prepare, conduct, and follow up on all types of GxP audits Support and lead clinical audit activities for internal and external parties to ensure compliance with standards and regulations Collaborate with Business Leads to resolve audit findings and non-compliance issues, including CAPA approval Review audit reports peer-wise Assist staff in preparing for customer audits Host client audits INSPECTION: Prepare investigational sites for regulatory inspections Guide staff in inspection readiness strategies Act as SME during inspections, providing training and support Manage team during inspections Host and manage regulatory inspections for clients QUALITY MANAGEMENT SYSTEM: Facilitate document generation and updates, ensuring compliance with regulations Support risk assessments and root cause analyses for Quality Issues Assist in preparing CAPA plans and tracking their completion Drive continuous improvement initiatives CLIENT INTERACTIONS: Support business development of external quality and compliance services Lead or attend client visits and meetings SUPPORT: Provide quality advice to internal and external clients Lead investigations of non-compliance events and CAPA implementation Identify systemic gaps and coordinate remediation efforts, escalating critical issues as needed Qualifications Degree in a scientific field (Life Science degree for Italy) Knowledge of clinical trial processes in CRO/pharma industry, including GCP/GxP regulations Experience in clinical trials, QA, and operations (minimum 5 years); CSV knowledge a plus Adherence to ethical and good clinical practices Excellent communication and interpersonal skills Ability to work independently and in teams, with multitasking skills Fluent in English, written and verbal Proficient in MS Office applications For candidates in Italy, applications from protected categories under art. 1 L. 68/99 are welcome. What We Offer Competitive compensation, benefits, and growth opportunities in a collaborative environment. Join a team dedicated to making a difference in patients' lives. About Us Founded over 29 years ago in Lund, Sweden, TFS is a full-service global CRO with over 800 professionals in more than 40 countries, specializing in therapeutic areas like Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide us in fostering a culture of innovation and excellence. Together, we make a difference. J-18808-Ljbffr