Overview

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 Freelance Associate Director, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland / Lund, Sweden or home based in UK, Italy or Portugal.About this role

As part of our

Quality and Compliance

team you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The

Freelance Associate Director, Quality Assurance (GCP Auditor)

works very closely with the Senior Director of Quality Management and deputises for them in all areas. They will have line management responsibilities.The

Freelance

Associate Director, Quality Assurance (GCP Auditor)

is capable of independently conducting work related to the development, improvement and daily management of the TFS QMS as well as managing the Quality Management System and the associated documentation. They manage the Annual Audit Plan and tracking of all audits. They will also manage the recording of issues (including complaints and serious breach), managing CAPA and Computerised Systems Validation.This person has a broad experience in clinical research and quality management and is able to provide support and advice throughout this area.Key Responsibilities

AUDITEnsure the Annual Audit Plan is prepared, followed and maintained along with the Audit Progress Report.Responsible for tracking all audit types and ensuring all are completedPrepare, conduct and follow up on all types of internal and external GxP auditsSupport and guide operational staff in preparing for customer auditsResponsible for hosting / facilitating customer audits of the company and/or projectsReview and approve audit reports for other quality management personnel and provide advice and direction as requiredAct as Quality Lead Auditor when applicableINSPECTIONAssist in preparing investigational sites for regulatory inspections, as requiredSupport and guide operational staff in preparing for inspections including analysing risks and developing inspection readiness strategyProvide training/preparation to the backroom support team; manage team during inspectionsHost regulatory inspections for clients, as requiredResponsible for hosting and managing regulatory inspections of TFS, as requiredQUALITY MANAGEMENT SYSTEMOversight, management and support of Quality Issues including review and approval of Risk ReviewsQI and Audit/Inspection CAPA including review and approval of CAPA plans; approval of closure of action items including effectiveness verification and Final QA Approval of CAPAOversight and management of Complaints, Potential Serious Breach and Potential Fraud and Scientific Misconduct investigations as appropriateContributes to continuous improvement of the organisation; supports development and improvement of the TFS Quality Management System; ensures teams receive facilitation to prepare and update all types of QMS documentsDevelops new and updates quality management QMS documents as requiredSUPPORTProvide quality management advice and support to all internal staff and departmentsEnsure continuous audit readiness, regulatory inspection support and monitoringVENDOR MANAGEMENTEnsure all GxP vendors are assessed, whether for clients or TFSInform Vendor Management when issues/complaints are raised and work with Vendor Management to resolve theseMETRICSResponsible for audit metrics and assisting with Quality Management metrics as requiredCLIENT INTERACTIONSHost Quality Committees with TFS business unitsProvide quality management advice and support to external clientsPerform client visits / attend client meetings when requiredBUSINESS DEVELOPMENTAssist in providing input into proposals and costings, including quality management and securing external quality management servicesAccompany business development colleagues on customer visits and participate in presentations when requiredMISCELLANEOUSReview MSAs / Quality Agreements and other agreements to ensure TFS can comply with quality sections and minimise risksOversight and management of all RFIs and RFPs to ensure they are completed accurately and fullyAct as trainer for Quality Management and all TFS staff, as neededPrepare and distribute the Regulatory Intelligence Newsletter quarterlyMaintain knowledge of applicable regulations and company GxP standards and proceduresParticipate in internal meetings as required and liaise with other departments as necessary; other tasks delegated by Senior Director Quality Management within scope of experienceQualificationsUniversity/college degree or equivalent industry experienceAwareness of global and local industry trends, government policies and regulations in the clinical trials and pharmacovigilance areaIn-depth knowledge of GxP (including CSV) regulations and guidancePrevious auditing experience is required, with thorough knowledge of requirements for GxP compliance; knowledge of GxP regulated computerized system validation activities and principlesPrevious audit management experienceGood computer skills (Word and Excel)Ability to work independently and efficientlyGood planning, organisation and problem-solving abilitiesFluent in English, both written and verbalSeveral years’ experience in clinical research (e.g., monitoring, data management, drug safety, training)Five to ten years’ experience of auditing in two to three GxP areasInternational travel to audit sites, worldwideMembership of a quality association (e.g. the Research Quality Association) is an advantageFor candidates based in Italy, you will need to be compliant with the Italian MoH Decree dated 15 November 2011 (G.U. n°11 dated 14 January 2012). We also welcome applications from candidates belonging to protected categories under art. 1 L. 68/99.What We Offer

We 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 Us

Our journey began over 29 years ago in Lund, Sweden. 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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