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.Join Our Team as a Senior Quality Manager / Quality Manager - home / office based in the UK, Italy, Spain or Poland.For candidates based in Italy - we welcome applications from candidates belonging to protected categories under art. 1 L. 68/99.About this RoleAs part of our Quality and Compliance team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.Key ResponsibilitiesComputer Systems Validation: Manage and lead all quality aspects of CSV and IT Security within TFS. Prepare, conduct and follow up on internal and external CSV / Computerised Systems audits including system/process audits and vendor audits. Mentor and train Quality Managers in CSV and IT Compliance as appropriate.Client Interactions: Assist with business development of external quality and compliance services. Lead / attend client visits / client meetings when required.RFIs: Provide input into the quality section of RFI / RFP and quality assessments; maintain a library of questions and robust agreed answers.Audit: Prepare, conduct and follow up on all types of internal and external GxP audits. Peer review of audit reports. Support and guide operational staff in preparing for customer audits. Hosting client audits.Inspection: Preparing investigational sites for regulatory inspections, as required. Guide operational staff in preparing for inspections including analyzing risks and developing inspection readiness strategy. Provide training/preparation to the backroom support team; manage team during inspections. Host and manage regulatory inspections for clients, as required.Quality Management System: Facilitate teams from across the company in generating/updating any QMS Documentation; driving the process to ensure no QMS document expires. Support staff from across the company to complete accurate and detailed risk assessments and root cause analysis for all quality events, ensuring all are completed on time and documentation is always suitable to share with clients as appropriate. Assist staff to prepare appropriate and robust CAPA Plans (for Quality Events) and track and manage these through to completion ensuring most CAPA are completed on the due date. Actively contribute to continuous improvement of the organization and development of routines to enhance the work at TFS.Support: Provide quality advice and support to internal clients.Miscellaneous: Prepare and present training as appropriate. Participate in internal meetings as required and liaise with other departments as necessary. Maintain required knowledge of applicable regulations and company GxP standards and procedures. Other tasks and activities delegated by the Senior Director Quality Management or Associate Director Quality Operations within scope of experience.QualificationsUniversity/college degree or equivalent industry experience.Awareness of the clinical trials area / pharma industry, including knowledge of GxP regulations.Two years' experience in clinical research (GCP), especially in the CSV and IT security field.Excellent interpersonal skills.CSV and IT security knowledge and experience is mandatory.Highly-analytical professional with strong attention to detail.Pro-active, recognizing and anticipating issues, addressing problems and developing solutions.Good planning, organization and problem-solving abilities.Demonstrated ability to multitask, prioritize, and complete objectives.Excellent oral and written communication skills.Fluent in English, both written and verbal.Advanced user of MS Office applications.What We OfferWe 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.A Bit More About UsOur journey began over 27 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. Our 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. Together we make a difference.
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