Associate Director, Validation Lead - Data & Digital

Novartis India; Hyderabad; On-site; INR 3,000,000 - 7,000,000; Full time

Job summary

Novartis India is seeking an Associate Director – Validation Lead, Data & Digital to drive TRD’s digital capability validation strategy and governance from Hyderabad’s Genome Valley.

You will partner with Data & Digital, IT, QA and external providers to ensure compliant validation across global programs, lead risk assessments, and guide audits while advancing data integrity and regulatory standards in a complex, matrix environment.

Qualifications

• 10+ years QA and computer system validation experience.
• 2+ years international/global exposure.
• Knowledge of global regulatory requirements across health authorities.
• Life sciences knowledge is an advantage.
• Experience in matrix organizations desirable.
• Excellent communication and interpersonal skills.

Responsibilities

• Lead TRD digital capability validation strategy with hands-on support.
• Collaborate with Data & Digital, IT, Business, QA and external providers to align standards.
• Own and maintain the validation master plan, ensuring inspection readiness.
• Monitor and improve validation performance metrics for compliance and operations.
• Provide leadership for validation risk assessments, investigations and complex challenges.
• Support new system implementations and ongoing validated operations.
• Ensure data integrity and regulatory compliance across the lifecycle.
• Represent TRD during audits, inspections and governance activities.
• Drive continuous improvement to validation effectiveness and performance.
• Review validation protocols, reports, and risk assessments.

Skills

Regulatory knowledge

Quality systems

Cross-functional collaboration

Stakeholder management

Education

Science degree

Job description

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 Requirements

• 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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