TRD QA Global Sterility Assurance

Establish, lead, and continuously develop a 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 across 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.

Location: Basel, Switzerland #hybrid

• Advanced degree (PhD, MSc, or equivalent) in life sciences, pharmacy, or related field

• Extensive experience in sterile manufacturing, quality assurance, or related areas within the pharmaceutical/biotech industry

• Strong knowledge of aseptic processing, sterility assurance, and regulatory requirements (e.g., FDA, EMA, ICH)

• Proven track record in leading cross-functional teams or networks, ideally in a matrix environment

• Demonstrated ability to influence without authority and drive change across organizational boundaries

• Excellent problem-solving, communication, and stakeholder management skills

• Fluent in English; additional languages a plus