Cell Therapy Compliance Manager

Vor 3 Tagen


Basel, Basel-Stadt, Schweiz Bayer AG Vollzeit

About the Role:

As a key member of our team, you will be responsible for ensuring the quality oversight of Cell and Gene Therapy products across all platforms and domains. This includes ensuring compliance with EMA, FDA, and other relevant regulations. You will provide CMC and QA expertise to CGT companies to prepare INDs, IMPDs, and BLAs for various markets.

Key Responsibilities:

  • Provide CMC and QA expertise for CGT companies, ensuring preparation of regulatory documents;
  • Act as the key QA expert and contact for Regulatory Affairs in CGT companies;
  • Support Quality Compliance oversight for CGT products throughout clinical and commercial phases;
  • Ensure QA compliance of regulatory documentation with EMA, FDA, and other regulations;
  • Contribute to regulatory strategy and establish control strategies across CGT;
  • Facilitate cross-functional regulatory support to expedite product submissions;
  • Develop strategies for efficient development and commercialization in collaboration with RA functions;
  • Support the establishment of CGT QMS & Compliance;
  • Promote knowledge exchange and best practices across CGT satellites and Bayer functions;
  • Serve as the Regulatory CMC interface for CGT products.

Requirements:

  1. PhD/MD in Biotechnology, Virology, Cell Engineering, Pharmaceutical Technology, or related field;
  2. 15 years of experience in the pharmaceutical industry;
  3. Strong understanding and hands-on experience with molecular biology methods;
  4. Required experience in a cGMP environment and writing regulatory documents for CGT products;
  5. Deep understanding of quality requirements for gene and cell therapy products;
  6. Exposure to diverse modalities in gene and cell therapies;
  7. Experience in GMP/GCP inspections for CGT products;
  8. Ability to implement systems and troubleshoot critical issues;
  9. Driven by creating value for the customer (patient);
  10. Fluent in English, with negotiation skills at the C level. Fluency in German will be a plus.


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