Quality Lead Data & Digital TRD QA

Key Responsibilities:

• Leads the global TRD QA DDI Network with a team of direct and/or indirect reports. Is a direct member of DDI teams and boards with our partner functions. Leads the TRD QA network meetings as well as regular review board meetings with the TRD QA organization. Ensures direct and close communication with all TRD QA platforms.
• Ensures DDI projects impacting TRD and/or TRD QA are well supported. Takes accountability to cover related changes by (GMP) change control. Acts as Single Point of Contact (SPOC) for TRD DDI Teams and ensures strong quality voice representation. Acts as Functional Representative for the “IT Systems” process.
• Drives the TRD QA DDI agenda including organizational upskilling. Establishes a DDI strategy for TRD QA. Drives external engagement and know-how exchange, regularly evaluates TRD QA capabilities / capacities and proposes improvement plans. Proposes and owns digital projects to improve ways of working in TRD GMP areas and within TRD QA.
• Develops quality know-how to enable extended use of AI tools in TRD in a GMP compliant manner.
• Leads complex global DDI projects directly or contributes as TRD QA representative. Is a member of global TRD and/or TRD QA Data & Digital Projects and acts as TRD QA SPOC. For complex projects with more than one TRD QA member: Leads the TRD QA sub-team and ensures “one voice” during decision making. Applies TRD QA project management standards and processes.
• Ensures high GMP standards during ideation, project phase and implementation. Holds the team accountable for GMP compliant change control execution.
• Is an ambassador of Novartis values and behaviors. Fosters an open and collaborative environment. Identifies needs and opportunities for support and encourage ideas to improve processes and day-to-day work.
• Applies AI based technologies as a role model enabling TRD QA to remain innovative, competitive and compliant.

Essential Requirements:

• Advanced degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
• 10+ years of experience in pharmaceutical industry with at least 3–5 years working on data and digital projects or data management.
• Deep knowledge in GXP regulations and regulatory compliance for computerized systems (US and EU standards and regulations).
• Demonstrated experience leading digital/AI initiatives in regulated pharma environments through stakeholder engagement, upskilling, and adoption campaigns
• Proven track record in successfully leading global and cross functional projects and teams.
• Strong interpersonal skills including diplomacy, persuasion, communication, collaboration, and senior stakeholder management.

Desirable Requirements:

• Lean six sigma greenbelt certifications.
• Experience with cloud-based quality systems, advanced analytics, or SaaS platforms in a regulated setting.
• Any certification in Data Science, Digital Transformation, or AI/ML.
• Participation or leadership in global digital quality networks or industry forums.
• Project Management Professional (PMP).

You’ll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 78,383.90 a year (on a full-time basis) in Austria. The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

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.