摘要
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
About the Role
- 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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Innovative Medicines
C028 (FCRS = CH028) Novartis Pharma AG
East Hanover, New Jersey, USA
Mengeš, Slovenia
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