Associate Director, Validation Lead - Data & Digital

Novartis; Hyderabad; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

Novartis AG in Hyderabad, Genome Valley, seeks an Associate Director - Validation Lead, Data & Digital to drive TRD's digital capability validation strategy and ensure high compliance standards across the system lifecycle.

You will collaborate with Data & Digital, IT, Quality, and external providers to standardize validation globally, own the master plan, and lead audits and inspections to sustain operational excellence.

Qualifications

• Master's or bachelor's degree in chemistry, pharmacy, chemical engineering, computer science, biological sciences, pharmaceutical technology, or related scientific discipline.
• 10+ years of QA and computer system validation experience, with at least 2 years in pharma/healthcare.
• 2+ years of international experience with Global teams.
• Strong knowledge of quality systems and global regulatory requirements across multiple health authorities.

Responsibilities

• Lead TRD's digital capability validation strategy and governance.
• Provide guidance and hands-on operational validation support to TRD teams.
• Own and maintain the validation master plan and ensure inspection readiness.
• Monitor and improve validation performance metrics for compliance and operational excellence.
• Provide leadership for validation risk assessments and investigations.
• Perform risk assessments and define validation approaches by system criticality and regulatory principles.
• Support new system implementations and validated operation of applications.
• Ensure data integrity and regulatory compliance across system lifecycles.
• Represent TRD during audits and validation governance activities.

Skills

Communication

Stakeholder engagement

Change management

Data governance

Data literacy

Data quality

Statistical analysis

Time series analysis

Machine learning

Neuro‑Linguistic Programming

Education

Master's or Bachelor's degree in chemistry, Pharmacy, Chemical Engineering, Computer Science, Biological Sciences, Pharmaceutical Technology, or related scientific discipline

Tools

Python

R Programming

SQL

Pandas Python Library

Job description

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).

Job Description

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.

Skills Desired:

Artificial Intelligence (AI), Biostatistics, Business Value Creation, Change Management, Curious Mindset, Data Governance, Data Literacy, Data Quality, Data Science, Data Visualization, Deep Learning, Generative AI, Graph Algorithms, Learning Agility, Machine Learning (ML), Machine Learning Algorithms, Neuro‑Linguistic Programming (NLP), Organizational Awareness, Pandas Python Library, Python (Programming Language), R Programming, Stakeholder Engagement, Statistical Analysis, Structured Query Language (SQL), Time Series Analysis