What you can expect:
- Develop and maintain the External Supply Operation's team's and organisation's quality standards
- Create a cross-functional quality infrastructure for ESO to provide comprehensive quality control of CMOs, accounting for regulatory compliance, GMP compliance, and qualification status
- Regularly check the products supplied by the CMOs for quality, and start projects to improve it
- Ensure that corrective and preventive actions (CAPA) are put into practice and that suppliers are informed of any changes or difficulties
- Competent authority inspection preparation activities and CMO assistance
- Create quality performance evaluations with metrics and techniques to increase supplier adherence to specifications, and lead associated meeting
- Work with suppliers to align the ESO Business Review's quality component with the CMO's strategic objectives
- Take part in the organisation of ESO as well as the selection and due diligence of strategic CMOs for new products and product transfers
- Create excellent teams for the External Supply Operations, taking care to carefully prepare for succession, talent management, and personal growth
- The candidate will drive process improvement by applying recognised quality tools, internal and external audit programmes, appropriate CAPA systems and feedback systems (complaints, etc.)
- You will participate in global projects and ensure their timely implementation
Who we are looking for:
- At least 10 years of experience in the pharmaceutical industry with demonstrated knowledge of the biotechnology sector, or at least 5 years of experience in the bio-pharmaceutical sector
- In-depth familiarity with EMA, FDA, and other regulatory standards governing the bio-tech and pharmaceutical industries in the US and Europe
- Bio-tech and pharmaceutical industry regulations
- Thorough understanding of pharmaceutical and biotechnology supply chain, manufacturing, and development
- A degree in the natural sciences, pharmaceutical sciences, or a closely connected discipline
- Possessing a master's degree in biotechnology is beneficial
- Proficient command of the English language
- Proven abilities in project management, collaboration, leadership, and communication
- Effective stakeholder management at the internal cross-functional and external matrix levels
- Internal and external interlocutors in a team environment
