Associate Director, Validation Lead - Data & Digital

### **Summary**

As part of the ARD Data \& Digital organization, the Associate Director – Validation Lead, Data \& Digital is accountable for leading TRD’s digital capability validation strategy execution and governance, ensuring systems are implemented/deployed with the highest standards of compliance. The position is based in the Genome Valley, Hyderabad, within the Technical Research and Development Organization (TRD) of Global Drug Development (GDD).

### **About the Role**

• *Major accountabilities:**

• Execute the TRD digital capability validation strategy, providing guidance and hands\-on operational support to TRD teams.
• Collaborate with Data \& Digital, IT, Business, Quality and external service providers to ensure consistent validation standards globally.
• Own and maintain the validation master plan, ensuring timely execution and inspection readiness.
• Establish, monitor and improve TRD digital capability validation performance metrics to support compliance and operational excellence.
• Provide technical leadership for validation risk assessments, investigations, and complex validation challenges.
• Perform risk and impact assessments and define appropriate validation approaches based on system criticality and regulatory principles.
• Support new system implementations, system changes and the ongoing compliant operation of validated applications.
• Ensure data integrity and regulatory compliance throughout the system lifecycle.
• Represent the TRD organization during audits, inspections, and validation governance activities while maintaining compliance standards.
• Driving continuous improvement initiatives to enhance validation effectiveness, compliance, and operational performance.
• Reviewing validation protocols, reports, risk assessments, and related technical documentation.

• *Essential Requirement:**

• Master’s or bachelor’s degree in chemistry, Pharmacy, Chemical Engineering, Computer Science, Biological Sciences, Pharmaceutical Technology, or a related scientific discipline.
• 10\+ years of relevant experience in quality assurance and computer system validation, with at least 2 years in Pharma/Healthcare. Cross\-industry experience highly preferred. 2\+ years of international experience working with Global teams.
• Strong knowledge of quality systems and global regulatory requirements across multiple health authorities.
• Knowledge of pharmaceutical and/or life sciences domain is an advantage
• Experience working in a matrix environment with cross\-functional stakeholders is desirable
• Excellent communication, negotiation, facilitation, and interpersonal skills.
• *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.

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Division

Development

Business Unit

Development

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS \= IN010\) Novartis Healthcare Private Limited

Functional Area

Data and Digital

Job Type

Full time

Employment Type

Regular

Shift Work

No

### **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.