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Novartis
TRD QA Global Sterility AssuranceNovartis • schaffhausen, Switzerland
TRD QA Global Sterility Assurance

TRD QA Global Sterility Assurance

Novartis • schaffhausen, Switzerland
Vor 16 Tagen
Stellenbeschreibung
ph3Role Purpose /h3 pProvide 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). 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. /p h3Summary /h3 pLocation: Basel, Switzerland #hybrid /p h3About The Role /h3 h3Major Accountabilities: /h3 ul liEstablish, lead, and continuously develop a TRD QA Sterile Operations Network, fostering accountability, learning, and collaboration. /li liProvide specialist knowledge and guidance on sterile and low bioburden processes, ensuring compliance with regulatory requirements. /li liImplement, 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). /li liDrive continuous improvement, knowledge transfer, and innovation in sterility assurance. /li liAct as a key partner in cross-functional projects, troubleshooting issues and aligning stakeholders on pragmatic solutions and standards. /li liMentor and develop members of the TRD QA Sterile Operations Network, addressing critical skills gaps. /li liConsult on the evaluation and selection of external contractors for aseptic appropriateness, ensuring integrity of outsourced processes. /li /ul h3Desired Skills /h3 ul liInfluence without authority in a matrix environment-build credibility, align stakeholders, and drive standards adoption. /li liProactive relationship-building-actively engage cross-functional partners to create momentum for change. /li liPragmatic risk-taking-balance diligence with smart, solution-oriented decision-making. /li liAdvanced problem-solving-lead troubleshooting and resolution across departmental boundaries. /li liEffective communication-tailor messaging, negotiate, and handle pushback diplomatically. /li liPolitical savvy-navigate informal networks and overcome barriers to secure a seat at the table. /li /ul h3Qualifications /h3 ul liAdvanced degree (PhD, MSc, or equivalent) in life sciences, pharmacy, or related field /li liExtensive experience in sterile manufacturing, quality assurance, or related areas within the pharmaceutical/biotech industry /li liStrong knowledge of aseptic processing, sterility assurance, and regulatory requirements (e.g., FDA, EMA, ICH) /li liProven track record in leading cross-functional teams or networks, ideally in a matrix environment /li liDemonstrated ability to influence without authority and drive change across organizational boundaries /li liExcellent problem-solving, communication, and stakeholder management skills /li liFluent in English; additional languages a plus /li /ul h3Benefits Rewards /h3 pAt Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. /p h3Expected Annual Base Salary Range for role: €133,700 to €248,300 /h3 pThe base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. /p pIn addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. /p pThe rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. /p h3Accessibility and accommodation /h3 pNovartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message. /p h3Why Novartis: /h3 pHelping 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? /p h3Benefits and Rewards: /h3 pLearn about all the ways we’ll help you thrive personally and professionally. /p pRead our handbook (PDF 30 MB) /p /p #J-18808-Ljbffr
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TRD QA Global Sterility Assurance • schaffhausen, Switzerland

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