Director, Global TRD QA Sterility Assurance

About the role

The Director, Global TRD QA Sterility Assurance will lead the TRD QA Sterile Operations Network, ensuring sterility and low‑bioburden processes meet regulatory standards across all TRD pilot plants and therapeutic modalities.

Key responsibilities

• 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 to ensure regulatory compliance.
• Implement, harmonise and improve aseptic standards and best practices across cell and gene therapy, radioligand therapy, ADC and new biological entity platforms.
• 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.
• Mentor and develop network members, addressing critical skill gaps.
• Consult on the evaluation and selection of external contractors for aseptic suitability, safeguarding outsourced process integrity.

Required profile

• Proven experience leading QA sterility or aseptic operations in a pharmaceutical or biotech environment.
• Deep understanding of regulatory requirements for sterile manufacturing (e.g., EU GMP, FDA).
• Ability to influence without formal authority in a matrix organization.
• Strong relationship‑building skills with cross‑functional teams.
• Demonstrated capability to mentor and develop technical staff.

Required skills

• Aseptic processing
• Sterility assurance
• Low bioburden processes