Manager GQS CSV & Digital Quality

Sandoz; Telangana; On-site; INR 2,400,000 - 3,600,000; Full time

Job summary

Sandoz in India seeks a senior Subject Matter Expert for Computerized System Validation (CSV), Digital Quality, Data Integrity, AI Governance and digital compliance across the organization. Provide quality and compliance oversight for GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies throughout their lifecycle.

Support the implementation of Compliance by Design, Quality by Design, digital transformation and process simplification initiatives

Qualifications

• Senior expert in CSV, Digital Quality, Data Integrity and AI Governance.
• Knowledge of GxP regulatory expectations and validation lifecycle.
• Experience with AI governance, data integrity and digital compliance.

Responsibilities

• Provide quality oversight for GxP computerized systems, digital platforms and AI capabilities throughout their lifecycle.
• Support CSV and Digital Quality frameworks, standards and procedures.
• Ensure compliance activities align with regulatory requirements and internal standards.
• Contribute to inspections, audits and remediation activities related to computerized systems and digital solutions.
• Identify compliance gaps and support CAPA and corrective actions.
• Partner with Quality, Digital and IT to enable compliant, efficient digital solutions across functions.
• Drive standardization of validation practices and digital quality processes.
• Promote continuous improvement through digitalization, automation and modern validation approaches.
• Provide guidance and training on CSV, Digital Quality and Data Integrity requirements.

Job description

Job Description Summary

• Serve as a senior subject matter expert for Computerized System Validation (CSV), Digital Quality, Data Integrity, AI Governance and digital compliance across the Sandoz organization.
• Provide quality and compliance oversight for GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies throughout their lifecycle.
• Support the implementation of Compliance by Design, Quality by Design, digital transformation and process simplification initiatives while ensuring alignment with applicable regulatory requirements and industry best practices.
• Partner with Quality, Digital and IT stakeholders to enable compliant, efficient and sustainable digital solutions across Development, Manufacturing, Quality, Supply Chain and Commercial functions.

Job Description

Position Purpose:
Serve as a senior subject matter expert for Computerized System Validation (CSV), Digital Quality, Data Integrity, AI Governance and digital compliance across the Sandoz organization. Provide quality and compliance oversight for GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies throughout their lifecycle. Support the implementation of Compliance by Design, Quality by Design, digital transformation and process simplification initiatives while ensuring alignment with applicable regulatory requirements and industry best practices. Partner with Quality, Digital and IT stakeholders to enable compliant, efficient and sustainable digital solutions across Development, Manufacturing, Quality, Supply Chain and Commercial functions.

Key Responsibilities

Your responsibilities include, but not limited to:

CSV & Digital Quality Oversight

• Provide quality oversight and guidance for GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies.
• Support implementation and maintenance of CSV and Digital Quality frameworks, standards and procedures.
• Ensure validation and compliance activities are conducted in accordance with applicable regulatory requirements and internal standards.
• Contribute to regulatory inspections, audits and remediation activities related to computerized systems and digital solutions.

Compliance & Risk Management

• Support compliance with global GxP requirements, Annex 11, 21 CFR Part 11, Data Integrity principles, GAMP5, CSA and applicable AI regulations.
• Perform risk assessments and support risk-based validation approaches for computerized systems and digital solutions.
• Review validation documentation and ensure compliance throughout the system lifecycle.
• Identify potential compliance gaps and support implementation of corrective and preventive actions.

End-to-End Digital Quality Support

• Maintain oversight of assigned digital solutions, computerized systems, interfaces and supporting processes.
• Support lifecycle activities including requirements, validation, implementation, operation, monitoring, change management and retirement.
• Drive standardization and harmonization of validation practices and digital quality processes.
• Identify opportunities to improve compliance, efficiency and effectiveness through digitalization, automation and modern validation approaches.

AI, Data & Automation Quality Assurance

• Provide quality oversight for AI, Generative AI, advanced analytics and intelligent automation solutions used in GxP-relevant processes.
• Support qualification, validation, monitoring and lifecycle management activities for AI-enabled solutions.
• Assess compliance risks associated with digital innovations and recommend appropriate controls.
• Support implementation of governance requirements for explainability, traceability and data integrity.

Business Partnership & Project Support

• Partner with Quality, Digital, IT and Business functions to ensure quality and compliance requirements are appropriately incorporated into digital initiatives.
• Participate in project teams as Digital Quality subject matter expert.
• Support deployment of new digital solutions and system enhancements.
• Provide guidance and training on CSV, Digital Quality and Data Integrity requirements.

Continuous Improvement & Knowledge Management

• Monitor regulatory developments, industry trends and emerging technologies relevant to CSV and Digital Quality.
• Support development and maintenance of standards, procedures, templates and best practices.
• Contribute to inspection readiness, continuous improvement initiatives and knowledge-sharing communities.
• Promote risk-based and pragmatic compliance approaches aligned with business objectives.

Key performance indicators:

• Compliance & Inspection Readiness
• Successful support of inspections, audits and compliance assessments.
• Timely closure of digital quality observations and CAPA