TRD QA Global Sterility Assurance

Location: Basel, Switzerland #hybrid Role Purpose: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).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.

Major Accountabilities: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.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.QualificationsAdvanced degree (PhD, MSc, or equivalent) in life sciences, pharmacy, or related fieldExtensive experience in sterile manufacturing, quality assurance, or related areas within the pharmaceutical/biotech industryStrong 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 environmentDemonstrated ability to influence without authority and drive change across organizational boundariesExcellent problem-solving, communication, and stakeholder management skillsFluent in English; additional languages a plusBenefits & RewardsAt Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.Expected Annual Base Salary Range for role: €133,700 to €248,300The 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.In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.The 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.Accessibility and accommodationNovartis 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 inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.