Translational Medicine G(c)LP Quality Lead

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