TRD QA Global Sterility Assurance

Salary Range:

CHF133700.00 - CHF248300.00

Job Description Summary

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.

Job Description

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 environmentbuild credibility align stakeholders and drive standards adoption.
• Proactive relationship-buildingactively engage cross-functional partners to create momentum for change.
• Pragmatic risk-takingbalance diligence with smart solution-oriented decision-making.
• Advanced problem-solvinglead troubleshooting and resolution across departmental boundaries.
• Effective communicationtailor messaging negotiate and handle pushback diplomatically.
• Political savvynavigate 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 were committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: 133700 to 248300

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 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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Employment Type : Full-Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 133700 - 248300