Director, Global TRD QA Sterility Assurance
Skills
About the role
Summary
Location: Schaftenau, Austria
Role Purpose:
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.
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: €85,300 to €158,300
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.
Adjustments for Applicants with Disabilities: If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
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.
Read our handbook (PDF 30 MB)
Primary location salary range
$0.00 - $0.00
Division
Development
Business Unit
Quality
Location
Austria
Site
Schaftenau
Company / Legal Entity
AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
Questions about this role
Want AI Applyd to auto-apply to roles like this?
We tailor your resume per posting, fill the forms, and track replies for you.