Job Description

Salary Range:

€66,918.00 - €117,800.00

Job Description Summary

Job Title: Senior Expert Science & Technology, Polarion Business Lead, GDPD (m/f/d)

#LI-Hybrid

Location: Schaftenau, Austria

As the development of drug-device combination products becomes increasingly complex, robust digital design controls and end-to-end traceability are essential. We are looking for a Polarion Business Lead to lead Polarion as GDPD's critical, GMP-compliant, cross-functional platform for product development and lifecycle management.

In this role, you will steer the GDPD Polarion business network, shape the platform roadmap and translate business and compliance needs into practical system enhancements. Combining business leadership with hands-on Polarion expertise, you will enable reliable operations, harmonized Design History File practices, reusable solutions and efficient document automation across functions and projects.

Job Description

Key Responsibilities:

• Lead the GDPD Polarion network, including Polarion Business Support and functional key users; facilitate key-user forums, backlog reviews and prioritization decisions
• Design and operationalize enhanced capabilities of Polarion and own the Polarion enhancement backlog and single request intake; consolidate, validate and prioritize requests with key users, process owners and project stakeholders.
• Coordinate releases, controlled changes and defect resolution with application support, IT and external Polarion specialists and lead the business oversight of Polarion interfaces, ensuring that interfaces are documented and maintained.
• Define and deliver the Polarion training program; coach Polarion Business Support and functional key users and strengthen self-service through a central knowledge base.
• Support the onboarding of new device projects, promote reuse of blueprints and drive harmonization, platforming and document automation across GDPD.
• Partner with functions, operational managers and project leaders to maximize Design History File synergies and ensure alignment with design control processes.
• Prepare budget proposals for enhancements and external support, track spending within approved budgets and contribute to the Polarion roadmap within the broader digital and data landscape in TRD.
• Ensure compliant and reliable operation in line with applicable quality, regulatory, information security, health, safety and environmental requirements; support continuous improvement and audit readiness.
• Define and monitor relevant KPIs, including support demand, backlog, adoption and training; identify and address capability or compliance gaps.
• Author and maintain procedures and work instructions related to Polarion and represent GDPD as Polarion subject-matter expert in internal and external audits.

Essential Requirements:

• Bachelor's degree or equivalent professional experience in Life Sciences, Engineering, Computer Science or a related field; a Master's or higher degree is desirable.
• Proven hands-on experience with Polarion ALM, including configuration, scripting or macros and templates, or comparable requirements and lifecycle management tools
• Experience working with computerized systems in a regulated GxP or medical-device environment, with a strong understanding of quality, compliance and controlled change.
• Knowledge of design controls and Design History File content for medical devices or drug-device combination products.
• Demonstrated ability to lead cross-functional networks and teams without direct line authority, manage competing priorities and drive decisions across organizational boundaries.
• Strong operational and project-management skills, including release coordination, issue resolution, stakeholder communication and structured execution.
• Fluent English, with strong written, presentation, facilitation and training skills.

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: €66,918 to €117,800

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.

Skills Desired