Associate Director Validation Lead - Data And Digital

Novartis India; Hyderabad; On-site; INR 2,400,000 - 4,200,000; Full time

Job summary

Novartis India is seeking an Associate Director – Validation Lead for the ARD Data & Digital domain. Based in Genome Valley, Hyderabad, you will drive validation strategy, governance and inspection readiness for TRD digital systems.

You’ll partner across IT, QA, business teams and external providers to ensure compliant, high‑quality implementations. You bring 10+ years in quality assurance and computer system validation, with pharma/healthcare experience and international collaboration.

Qualifications

• 10+ years of QA and computer system validation experience, with pharma/healthcare exposure.
• 2+ years of international experience with Global teams.
• Knowledge of global regulatory requirements and quality systems.

Responsibilities

• Execute TRD digital capability validation strategy and provide hands‑on support.
• Collaborate with IT, data & digital, business, quality and external providers to standardize validation.
• Own the validation master plan and ensure inspection readiness.
• Monitor metrics to improve compliance and performance.
• Lead validation risk assessments and investigations for complex challenges.
• Support new system implementations and ongoing validated operations.
• Represent TRD in audits and validation governance activities.
• Drive continuous improvement for validation effectiveness and compliance.
• Review validation protocols, reports and related documentation.

Skills

Quality assurance

Computer system validation

Regulatory compliance

Cross‑functional collaboration

Risk assessment

Education

Master’s or Bachelor’s degree in chemistry, pharmacy, chemical engineering, computer science, biological sciences, pharmaceutical technology

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 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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