We are seeking a highly independent and experienced Global Specialist with a strong background in compliance within cell therapy and biopharmaceuticals.
This role will focus on ensuring compliance across enterprise-level QMS, with particular emphasis on supporting system updates and enabling functions.
Key Responsibilities:
- Ensure compliance in cell therapy within enterprise-level QMS, particularly focusing on system updates and enabling functions
- Provide expert guidance on managing complaints, deviations, and change controls with an enabling approach, rather than direct operational involvement
- Support global launches of cell therapy products, with particular emphasis on emerging markets in Asia
- Lead and manage audits to ensure compliance in cell therapy, with a specific focus on raw materials and vector usage
- Stay updated on global regulatory requirements and ensure that all cell therapy operations adhere to these standards
Requirements:
- Extensive experience in cell therapy and biopharmaceutical compliance
- Proven capability to operate independently and lead compliance functions in a global environment
- Experience with launches of cell therapy products
- Proficient in English; additional languages are a plus
- Experience with Veeva Systems and Salesforce is required
*Remote position*
For further information about this position, please apply with your CV
*Please note, only those with the right to work in Switzerland can apply!
