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