TRD QA Global Sterility Assurance

Novartis; Basel; Hybrid; CHF 124.406 - 231.040; Vollzeit

Zusammenfassung

Novartis Basel is seeking a senior leader to provide expert guidance on sterile and low bioburden processes across TRD pilot plants and modalities, ensuring regulatory compliance and continuous improvement in aseptic standards.

You will mentor the QA Sterile Operations Network, drive knowledge transfer, and collaborate with cross-functional teams to align stakeholders on pragmatic solutions, while supervising contractor selection for outsourced processes.

Qualifikationen

• Advanced degree required in life sciences/pharmacy or related field.
• Proven ability to influence and drive change across matrix organizations.
• Experience with sterile manufacturing, quality assurance, and regulatory requirements (FDA/EMA/ICH).

Aufgaben

• Establish and lead the TRD QA Sterile Operations Network.
• Provide specialist knowledge on sterile and low bioburden processes.
• Implement and harmonize aseptic standards across modalities (Cell & Gene Therapies, Radioligand Therapies, ADC, NBEs).
• Drive continuous improvement and knowledge transfer in sterility assurance.
• Partner in cross-functional projects, troubleshooting and aligning stakeholders on standards.
• Mentor members of the QA Sterile Operations Network to address skills gaps.
• Evaluate and select external contractors for aseptic appropriateness.

Kenntnisse

Influence without authority

Relationship-building

Pragmatic risk-taking

Advanced problem-solving

Effective communication

Political savvy

Ausbildung

PhD or MSc in life sciences/pharmacy/related field

Jobbeschreibung

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.

Summary

Location: Basel, Switzerland #hybrid

About The Role

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.

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

Benefits & Rewards

At 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 €248,300

The 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 accommodation

Novartis 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 [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

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