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Freelance Associate Director, Quality Assurance (GCP Auditor) (0.8-1.0 FTE)

Freelance Associate Director, Quality Assurance (GCP Auditor) (0.8-1.0 FTE)

TFS HealthScienceLisboa, Lisboa, Portugal
Há 1 dia
Descrição do cargo

Overview

Freelance Associate Director, Quality Assurance (GCP Auditor) (0.8-1.0 FTE). Hybrid in Warsaw, Poland / Lund, Sweden or home based in UK, Italy or Portugal. Join the Quality and Compliance team to support the development, improvement and daily management of the TFS QMS, manage the Annual Audit Plan, and provide expert QA guidance in GxP environments.

About this role : The Freelance Associate Director works closely with the Senior Director of Quality Management, deputises in all areas, and has line management responsibilities. This role requires strong clinical research and quality management experience and the ability to provide support and advice across the quality function.

Key Responsibilities

  • AUDIT :

Prepare, follow and maintain the Annual Audit Plan and Audit Progress Report

  • Track all audit types and ensure completion
  • Prepare, conduct and follow up on internal and external GxP audits
  • Support and guide operational staff in preparing for customer audits
  • Host / facilitate customer audits of the company and / or projects
  • Review and approve audit reports and provide guidance as needed
  • Act as Quality Lead Auditor when applicable
  • INSPECTION :

    • Assist in preparing investigational sites for regulatory inspections

  • Support staff in inspection readiness planning and risk analysis
  • Provide training and manage the support team during inspections
  • Host regulatory inspections for clients and for TFS
  • QUALITY MANAGEMENT SYSTEM :

    • Oversee and support Quality Issues, including Risk Reviews

  • Oversee CAPA processes and closure, with effectiveness verification
  • Manage investigations for Complaints, Potential Serious Breach and Potential Fraud / Scientific Misconduct
  • Contribute to continuous improvement of TFS QMS; develop / update QMS documents; facilitate training
  • SUPPORT :

    • Provide QA advice to internal staff; ensure ongoing audit readiness and inspection support

  • VENDOR MANAGEMENT :

    • Assess GxP vendors; coordinate with Vendor Management to resolve issues

  • METRICS :

    • Own audit metrics and assist with QMS metrics as required

  • CLIENT INTERACTIONS :

    • Host Quality Committees with TFS units; advise external clients; participate in client visits / meetings

  • BUSINESS DEVELOPMENT :

    • Contribute to proposals and costings including QMS considerations; accompany BD colleagues on customer visits

  • MISCELLANEOUS :

    • Review MSAs / Quality Agreements; manage RFIs / RFPs; provide training; issue quarterly Regulatory Intelligence Newsletter; maintain knowledge of applicable regulations

    Qualifications

  • University / college degree or equivalent industry experience
  • Strong knowledge of global / local regulations in clinical trials and pharmacovigilance
  • In-depth knowledge of GxP (including CSV) regulations and guidance
  • Proven auditing experience with GxP compliance; knowledge of CSV concepts
  • Good computer skills (Microsoft Word and Excel)
  • Ability to work independently with good planning, organization and problem-solving skills
  • Fluent in English (written and verbal)
  • Several years of experience in clinical research (monitoring, data management, pharmacovigilance, training, etc.)
  • 5–10 years of auditing across two to three GxP areas; willingness to travel internationally
  • Membership in a quality association is a plus

    • For candidates based in Italy, compliance with Italian MoH Decree dated 15 November 2011 is required; we also welcome applications from candidates belonging to protected categories under art. 1 L. 68 / 99.

    What We Offer

    Competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. We value collaboration, innovation, and making a difference in patients’ lives.

    About Us

    TFS HealthScience is a global mid-size Contract Research Organization (CRO) delivering full-service clinical development and resourcing solutions across 40+ countries. We pursue Trust, Quality, Passion, Flexibility, and Sustainability in our work while supporting more than 800 professionals worldwide.

    Together we make a difference.

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    Quality Assurance • Lisboa, Lisboa, Portugal