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