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Clinical Quality Assurance Manager

Clinical Quality Assurance Manager (BBBH593982) Lausanne, Suisse


Description

 

Clinical Quality Assurance Manager


Your responsibilities will be but not limited to:

  • Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability”
  • Contribute to CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process to establish a pro-active quality approach, guaranteeing compliance with regulatory requirements
  • Collaborate with the Clinical Trial Manager and other Functional Area Representatives 
  • Provide compliance support 
  • Collaborate cross-functionally to the development and review of critical clinical study documents 
  • Applying the risk-based approach, identify the need to & conduct co-auditing activities / quality visits with DPI and / or CRO representatives
  • Provide continuous compliance support by acting as an internal advisor 
  • Create KQI to identify areas for improvement based on risk-based compliance activities and audit observations
  • Lead / contribute to compound-specific Regulatory Authority Inspections / Due Diligence Activities
  • Provide Audit / CAPA support to the execution of Master Audit

Requirements

  • University Degree in Sciences or relevant academic background
  • 6-8 years’ experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & Compliance
  • Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites and CSR)
  • Excellence knowledge of GCP. Current and strong working knowledge of GCP, CFR Title 21 and regulatory guidance’s including, ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance
  • Strong experience in the mechanism of multiple QA vendor’s oversight
  • Experience in setting and updating SOPs
  • Knowledge of computerized systems validation
  • Rigor, flexibility, adaptability and organization
  • Pragmatism focused on efficiency and continuous improvement
  • Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities
  • Fluent in English, French an asset

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