Tasks

  • Set up the GVP department and build a team from scratch
  • Manage and oversee QA activities related to current regulations and provide GVP expertise throughout the entire drug lifecycle (Phase 1-4)
  • Performing GVP audits to ensure compliance with regulatory requirements and internal standards
  • Regular exchange with authorities
  • Develop and revise SOP’s
  • Responsible for budget planning and tracking
  • Lead a team of Quality professionals and consultants
  • Implement key QA systems (investigations, deviations, audits, etc.)
  • Monitor trends and report issues to senior management
  • Participate in meetings and represent Clinical Quality
  • Define metrics for assessment and continuous improvement
  • Provide coaching and mentoring to junior staff
  • Lead strategic collaborations
  • Coordinate and host inspections
  • Promote continuous improvement

Qualifications

  • At least 10 years of experience in GVP environment
  • Strung understanding of international GVP requirements
  • Experience in international PV quality assurance and audits
  • Knowledge of requirements for development and established products
  • Willingness to travel on a regional and global basis for audits
  • Experience in setting up a department and leadership experience
  • Excellent English language skills, additional languages are a plus
  • Proficiency in MS Office