Head GQS CSV & Digital Quality

Job Description Summary

Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
Lead the enterprise-wide CSV & Digital Quality function, ensuring that Sandoz's GxP computerized systems, digital solutions, data platforms, AI capabilities and automation technologies remain compliant, inspection-ready, scalable, and business-enabling. Provide an enterprise view across the end-to-end digital ecosystem, ensuring consistent governance, risk management, compliance, and lifecycle oversight from business requirements and solution design through implementation, operation, change management, and retirement. Drive Compliance by Design, Quality by Design, digital transformation and process simplification across Development, Manufacturing, Quality, Supply Chain and Commercial functions.

Job Description

Major accountabilities: 

Enterprise CSV & Digital Quality Leadership

• Define and execute the enterprise-wide CSV & Digital Quality strategy.

• Establish and maintain a long-term roadmap for digital quality capabilities and compliance frameworks.

• Provide enterprise-level oversight of GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies.

• Act as the senior Quality advisor for digital transformation initiatives and emerging technologies.

• Represent Digital Quality during regulatory inspections, audits and governance boards.

Enterprise Governance & Compliance

• Establish and maintain governance frameworks for computerized systems, AI solutions, cloud platforms, automation technologies and digital products.

• Ensure compliance with global GxP requirements, Annex 11, 21 CFR Part 11, Data Integrity principles, GAMP5, CSA and applicable AI regulations.

• Define and drive risk-based validation and assurance approaches across the enterprise.

• Ensure inspection readiness and regulatory compliance throughout the digital solution lifecycle.

End-to-End Digital Quality Oversight

• Maintain an enterprise-wide view of digital quality processes, systems, data flows and interfaces across functions.

• Ensure end-to-end oversight and alignment from business requirements, design and implementation through operation, monitoring and continuous improvement.

• Drive harmonization, simplification and standardization of digital quality processes globally.

• Identify opportunities to leverage digitalization, automation and AI to improve compliance, efficiency and business outcomes.

AI, Data & Automation Governance

• Establish and maintain governance for AI, Generative AI, advanced analytics and intelligent automation solutions.

• Ensure appropriate qualification, validation, monitoring and lifecycle management of GxP-relevant AI solutions.

• Define controls for explainability, traceability, risk management and regulatory compliance.

• Provide quality oversight for automated and autonomous decision-support capabilities.

Digital Portfolio & Business Partnership

• Provide strategic quality oversight for enterprise platforms and digital products.

• Ensure quality and compliance requirements are integrated throughout concept, design, implementation and operation.

• Partner with Quality, Digital, IT and Business leaders to accelerate digital transformation while maintaining compliance.

• Support prioritization of digital investments from a quality and compliance perspective.

Organization & Capability Development

• Build and develop a high-performing organization with expertise in CSV, Digital Quality, Data Integrity, AI Governance, Risk Management and Supplier Digital Compliance.

• Define future capability needs and develop talent pipelines.

• Foster collaboration and communities of practice across Quality, Digital and IT organizations.

Minimum Requirements: 

Work Experience:

• Minimum 15 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance (must have)

• 15-20 years of overall experience, and a minimum 15 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance.

• Solid understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements, EMA Annex 11.

• Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)

• Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements.

• Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments

• Experience in quality management of onsite, Cloud, SaaS platform, mobile and digital applications used in regulated environments.

• Highly experienced in the operational management of GxP solutions including its related technologies to support the operation. Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.).

• Experience in the development, implementation and lifecycle management of key computerized systems in Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, Veeva, LIMS, CDS, etc.).

• Experience wrt. usage of AI within the GxP regulated environment (incl. Agentic AI, LLM). Successful cross-divisional/functional work with complex international teams.

• Good experience in ensuring the compliance of GxP application validation and Infrastructure Qualification. Good experience in GxP supplier qualification activities.

• Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude. Proven ability to effectively interact and present to Management, health authority inspectors.

• Proven ability to influence without hierarchical authority and build trusted partnerships. Proven self-starter with experience in initiating and delivering projects and processes. Excellent communication, negotiation, facilitation, interpersonal skills and critical thinking.

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 good health. 

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.

#Sandoz

Skills Desired

Agility, Agility, Business Acumen, Business Partnering, Business Strategy, Collaboration / Teamwork, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Leadership, Logical Thinking, People Management, Problem Solving Skill, Problem Solving Skills, Qa (Quality Assurance), Quality Management Systems (QMS), Quality Standards, Self-Awareness, Smart Risk Taking {+ 4 more}