Requirements: English
Company: TFS HealthScience
Region: italia ,
Freelancer Senior Quality Manager, Quality AssuranceTFS 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 a Freelance Senior Manager, Quality Assurance - UK, Poland, Spain, Portugal, or ItalyAbout this roleAs part of our Quality and Compliance Department, you will work alongside passionate professionals to ensure our customers achieve their goals.The Senior Manager, Quality Assurance is responsible for overseeing GCP activities related to clinical trials. They perform daily clinical quality operations and compliance activities to support successful clinical trial projects, ensuring processes adhere to regulatory requirements, ICH Guidelines (e.g., ICH E6 GCP), SOPs, country-specific requirements, and industry standards.The role includes facilitating controlled document management, supporting risk assessments and root cause analyses, managing quality issues, assisting with GxP Computer System Validation (CSV), and preparing for and hosting audits and inspections.Key ResponsibilitiesQuality Management System: Facilitate document updates, support risk assessments and CAPA plans, and promote continuous quality improvement.Inspection: Prepare sites for inspections, guide staff, manage inspection processes, and host external audits.Audit: Conduct and follow up on audits, support audit activities, and review audit reports.Computer Systems Validation: Assist with CSV activities across the company.RFIs/RFPs: Contribute to quality sections and maintain question libraries.Client Interactions: Support business development, lead client visits, and meetings.Support: Provide quality advice, lead investigations, and address systemic gaps and non-compliance issues.QualificationsDegree in a scientific field.Knowledge of GCP/GxP regulations and clinical trial processes.Minimum five years experience in clinical trials, QA, and GxP compliance; CSV experience is a plus.Strong communication, analytical skills, and ability to work independently and within a team.Fluent in English, proficient in MS Office.What We OfferCompetitive compensation, benefits, and growth opportunities in a collaborative environment dedicated to making a difference in patients lives.About UsFounded over 27 years ago in Sweden, TFS HealthScience is a global CRO delivering tailored clinical research services across therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology, with over 800 professionals in more than 40 countries.Our core valuesTrust, Quality, Passion, Flexibility, and Sustainabilityguide our decisions and culture. We are committed to mutual respect, innovation, and excellence. Together we make a difference.#J-18808-Ljbffr