Global Aseptic Network Lead bei Novartis

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:

• Influence without authority in a matrix environment—build credibility, align stakeholders, and drive standards adoption.
• Proactive relationship-building—actively engage cross-functional partners to create momentum for change.
• Pragmatic risk-taking—balance diligence with smart, solution-oriented decision-making.
• Advanced problem-solving—lead troubleshooting and resolution across departmental boundaries.
• Effective communication—tailor messaging, negotiate, and handle pushback diplomatically.
• Political savvy—navigate informal networks and overcome barriers to secure a seat at the table.

Qualifications

• 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

 

Skills Desired

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