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.
Your 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.
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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.
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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.
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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.
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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 CAPAs.
- Inspection readiness of assigned systems and digital solutions.
Digital Quality Excellence
- Adoption of risk-based validation and CSA approaches.
- Timely completion of validation deliverables and quality reviews.
- Improved standardization and efficiency of validation activities.
Digital Transformation Support
- Effective support of digital initiatives and system implementations.
- Integration of Compliance by Design principles into project delivery.
- Positive stakeholder feedback and business partnership.
AI & Digital Governance
- Timely completion of AI and digital compliance assessments.
- Effective support of AI governance requirements.
- Sustainable implementation of compliant digital innovations.
What you’ll bring to the role:
Essential Requirements:
- 10-15 years of overall experience with significant experience in CSV, Digital Quality, IT Quality or GxP Compliance within the pharmaceutical industry.
- Strong understanding of global regulations and Health Authority expectations governing computerized systems validation, lifecycle management, Data Integrity and 21 CFR Part 11 requirements.
- Experience supporting development, implementation and lifecycle management of computerized systems in regulated environments.
- Experience with Cloud, SaaS, digital and AI-enabled platforms used in GxP environments.
- Experience with validation and quality oversight of systems such as SAP, ERP, Veeva, MES, LIMS, CDS and related platforms.
- Understanding of AI, Generative AI and advanced analytics deployment within regulated environments.
- Experience working in cross-functional and global project teams.
- Experience supporting supplier qualification and computerized system compliance activities.
- Strong communication, influencing and stakeholder management skills.
- Proven ability to work independently, manage multiple priorities and deliver results in a complex matrix environment
Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more, so that everyone can achieve the basic human right of access to good healthcare.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Agility, Business Acumen, Business Partnering, Collaboration / Teamwork, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gmp Procedures, Goal-Oriented, Health Authorities, Leadership, Logical Thinking, Problem Solving Skill, Problem Solving Skills, Qa (Quality Assurance), Self-Awareness, Smart Risk Taking, Sop (Standard Operating Procedure) , Technological Expertise
