CMC Vendor Management Leader - Mechelen, BE
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe and the US.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
We are looking for a CMC Vendor Management Leader.
Develop and maintain a CMC vendor management process/system in collaboration with the Quality department and CMC department and adequately manage and follow up external CMC vendors with regards to overall quality and key performance indicators (KPI) and CAPA management and implementation.
- Develop processes, SOPs and systems to adequately manage and review the performance from a quality perspective of CMC external vendors in collaboration with CMC department and Quality department
- Install and maintain a working relationship with the Galapagos CMC department and Quality department in order to align on the vendor management approach
- Ensure vendor management processes and systems are embedded in the Quality Management System.
- Manage the CMC vendor audit masterplan in alignment with the CMC department and prepare vendor audits.
- Review vendor audit reports and develop CAPA plans with external CMC vendors in collaboration with Quality department.
- Pro- actively follow up and monitor timely CAPA implementation by external CMC vendors with robust and timely processes for root cause analysis, verification of actions and effectiveness checks
- Define, implement and monitor key performance indicators allowing adequate CMC vendor management including trend analysis on vendor performance
- Provide quality evaluation input for new vendor selection or selection of current vendors for new projects
Who are you?
Education (add qualification if relevant) & experience:
- Master Degree in Chemical, Pharmaceutical, Bio-Engineering or Biomedical Sciences with relevant experience in development, manufacturing or quality area’s.
- Good knowledge of quality guidelines. Experience in quality audits is an asset.
- Excellent verbal and written English language skills required.
- Ability to actively listen and engage in constructive communication with the different team members.
- Good organizational skills
- Excellent team player
- Excellence in planning, organising and supervising projects