Global Aseptic Network Lead

Job Description Summary

In this role you will be accountable for establishing, leading, and continuously developing the TRD QA Sterile Operations Network to ensure phase-appropriate, best-in-class sterile standards, knowledge sharing, and cross-functional collaboration that drive quality, compliance, and innovation across all modalities

Job Description

• Establish, lead, and continuously develop the TRD QA Sterile Operations Network, fostering accountability, learning, and collaboration.
• Provide specialist knowledge and guidance on sterile and low bioburden processes, ensuring compliance with regulatory requirements.
• Implement, harmonize, and continuously improve aseptic standards and best practices across TRD pilot plants and all modalities (Cell and Gene Therapies, Radioligand Therapies, ADC, and New Biological Entities).
• Drive continuous improvement, knowledge transfer, and innovation in sterility assurance.
• Act as a key partner in cross-functional projects, troubleshooting issues and aligning stakeholders on pragmatic solutions and standards.
• Mentor and develop members of the TRD QA Sterile Operations Network, addressing critical skills gaps.
• Consult on the evaluation and selection of external contractors for aseptic appropriateness, ensuring integrity of outsourced processes.

Desired skills :

Qualifications

Skills Desired