Translational Medicine G(c)LP Quality Lead

Posted 2 years ago

Key responsibilities:

  •  Contribute to Vendor selection and qualification process, assess Vendor’s procedures during selection process, guaranteeing compliance with regulatory requirements & verify G(c)LP certification, for TM vendors contributing to numerous PK & biomarkers assessments in DPI’s pre-clinical and clinical programs
  • Collaborate with the TM Subject Matter Experts to ensure proper DPI set-up & oversight of outsourced activities
  • Support “risk/impact assessments” related to TM activities & respective vendors contributing to DPI pre-clinical and clinical programs
  • Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation
  • Create Key Quality Indicators 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
  • Build collaborative working relationships and ensure adequate communication within the TM organization and cross-functional Quality peers
  • Lead coordinating the execution of Master Audit Plan executed by external auditors, assist the
    TM business stakeholders to ensure proper CAPA formulation and follow-up
  • Contribute to the development/maintenance of Quality and Translational Medicine related  Procedural Documents
  • Ensure training on proper knowledge and understanding on latest G(c)LP guidelines, DPIs. Procedural Documents and regulations of identified stakeholdersYour profile:
  • A master’s degree in a scientific discipline or equivalent combination of education and experience
  • 7 – 10 years’ experience in the Pharmaceutical of Biotechnology industry with a minimum of 5 years in Quality Management or Regulatory Compliance Role
  • Current and working solid knowledge in GLP, GcLP and regulatory guidance including, ICH, quality, non-clinical, clinical, multidisciplinary guidance documents and 21 CFR Part 11 compliance
  • Ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization
  • Strong problem-solving and analytical skills
  • Knowledge of root cause analysis tools/methodologies
  • Strong team player, with excellent interpersonal communication skills
  • Used to simultaneously support multiple projects, duties and assignments and prioritize accordingly
  • Self-dependent way of working; taking ownership of assigned tasks; plan and deliver according to agreed timelines

Job Features

Job CategoryRESEARCH

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