Job Description

Summary The Quality Lead Data & Digital TRD QA is responsible for overseeing, driving and implementing global data & digital (DDI) projects and initiatives within Technical Research and Development (TRD) Quality Assurance (QA). This role collaborates closely with relevant partners in TRD, Research & Development Quality (RDQ) and Operations Quality and leads the TRD QA DDI Network. The role incumbent ensures all DDI projects and related business processes are well supported by TRD QA and covered by change control as applicable. The role owner also drives digitalization and artificial intelligence (AI) solutions within TRD QA and is the "Go to person" for related topics within this organization.

• 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.
• Lean six sigma greenbelt certification
• 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)

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
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
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
Skills Desired Agility, Auditing, Audit Management, Business Partnering, Continued Learning, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, ISO 9001, Leadership, Organizational Savvy, People Management, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Stakeholder Management, Technological Expertise, Vendor Management

Skills Required