Sr, Digital Quality (SAP)

Purpose of this position :
Position in a global environment, responsible for defining, governing and continuously advancing the Digital Quality ecosystem across ZEISS Vision Care/ ZEISS COM. The role owns the Digital Quality strategy and roadmap, ensuring alignment between Quality, Regulatory Affairs, Operations, Business Functions, e.g. Procurement, Manufacturing, Supply Chain and IT.
Responsible for leading digital quality initiatives, including the Quality work package within the international implementation of SAP S/4HANA and the integration of multiple eQMS and digital platforms (e.g., Polarion, Salesforce, Veeva, eDMS [OpenText etc.]). The role focuses on defining, harmonizing and optimizing business processes within a Digital Quality ecosystem, considering system interfaces, AI-enabled solutions, Prompt Governance, data governance and advanced analytics (reports, dashboards) across multiple manufacturing and distribution sites as well as headquarters. The incumbent acts as the global business lead for Digital Quality capabilities and is ac-countable for ensuring that digital platforms, AI-enabled quality solutions and quality data architectures support business objectives while maintaining regulatory compliance, data integrity and audit readiness.
Primary duties and responsibilities
Digital Transformation
Actively participate in all activities required for the implementation of digital compliance systems impacting business processes (primarily SAP S/4HANA, including interfaces to other systems such as Polarion, Salesforce, and other eQMS platforms)
Lead the Quality Management (QM) work package within the global SAP S/4HANA implementation project
Analyze newly defined and existing S/4HANA processes for feasibility in high-volume, highly regulated environments
Collaborate with functions and business units to Identify requirements
Aligning requirements with global quality representative’s prior implementation
Implement changes within the digital compliance process landscape
Map end-to-end processes and system interfaces, identifying risks, including process efficiency and compliance risks
Support global rollout activities, including system validation and testing of SAP use cases
Troubleshoot post-implementation issues and recommend feasible, compliant solutions
Work autonomously to gather required information and collaborate with relevant stakeholders
Act proactively, deriving conclusions and driving decisions based on limited or incomplete information
Ensure timely and effective communication with all relevant stakeholders
Support additional activities as required by line management
Own the Quality Management digital compliance transformation Quality Plan, roadmap and related governance activities
Define target-state Digital Quality process architectures and system integration concepts
Lead cross-functional Digital Quality transformation initiatives across regions and sites
Drive harmonization and standardization of quality processes globally
Process Ownership of CSV / CSA, User Access Control
Ensure business ownership, adoption and sustainability of implemented Digital Quality solutions
Support prioritization of Digital Quality investments and resource allocation in alignment with business priorities
Digital Quality Strategy & Governance:
Own and continuously develop the global Digital Quality Strategy
Define and maintain the Digital Quality roadmap aligned with business objectives and regulatory requirements
Establish governance models for Digital Quality initiatives, systems and processes
Prioritize Digital Quality projects and transformation activities based on business value, risk and compliance impact
Act as business owner for the Digital Quality portfolio and strategic initiatives
Define Digital Quality standards, principles and minimum requirements across ZEISS Vision Care
Provide recommendations regarding Digital Quality investments, capabilities and technology opportunities
Ensure alignment between Quality, Regulatory Affairs, Operations, Business Functions and IT
AI & Digital Quality Innovation
Identify and drive opportunities for AI-enabled quality improvements (e.g., automation, predictive quality, AI agents and intel-ligent workflows)
Support the creation, training and deployment of AI agents to enhance quality processes and decision-making
Establish and maintain governance for AI-enabled quality solutions
Own Prompt Governance and Prompt Lifecycle Management for quality-relevant AI applications
Define standards for prompt development, validation, documentation, monitoring and continual improvement
Maintain approved prompt libraries and quality-specific AI instructions
Ensure traceability, auditability and version control of prompts and AI-generated outputs
Define validation requirements for AI-enabled solutions and support implementation of risk-based controls
Ensure AI-based solutions comply with regulatory, quality and data governance requirements
Contribute to continuous improvement and innovation within the Digital Quality landscape
Drive adoption of Generative AI capabilities, advanced analytics and intelligent automation within Quality processes
Data Governance :
Define and implement data governance standards for quality-relevant data across SAP, eQMS, and interfacing systems
Ensure data integrity, consistency, and traceability across the digital ecosystem
Define data ownership, data flows, and lifecycle management for quality data
Monitor and mitigate data-related risks impacting compliance and business processes
Own Quality Data Governance standards across Digital Quality platforms
Define Quality Data ownership, stewardship and accountability models
Lead development of the Quality Data Strategy supporting analytics, reporting and AI-enabled decision making
Establish standards for quality-related master data management
Drive implementation of quality dashboards and advanced reporting capabilities
Ensure availability of quality-relevant data for digital transformation initiatives
Portfolio Management & Vendor Governance
Own the Digital Quality application, project and initiative portfolio
Support budget planning and investment prioritization for Digital Quality initiatives
Evaluate emerging technologies and their applicability within Digital Quality
Establish and maintain strategic partnerships with Digital Quality solution providers
Support vendor selection, performance evaluation and governance activities for Digital Quality platforms and related services
Monitor portfolio performance and realization of business benefits
Quality Management System
Review and provide feedback on global Quality work package documentation and implementation processes to ensure compliance with the Quality Management System and ISO 13485, MDSAP, NMPA requirements
Create and maintain QMS documentation (procedures, work instructions, digital process documentation) required for compliance and successful system implementation in context with CSV/CSA
Ensure alignment of digital systems with regulatory requirements (e.g., ISO 13485, MDR, GxP, FDA 21 CFR)
Support QMS team in additional digital quality-related activities e.g. AI Agent implementation as required by line management.
Key Data
1. Leadership accountability
provides functional and disciplinary leadership for Digital Quality initiatives, Digital Quality champions, business process owners and cross-functional project teams within a global matrix organization across sites, regions and functions. Leads the Digital Quality community through governance structures, influence leadership and strategic alignment of priorities.
2. Supervisory dimension
CSV/CSA Manager
Digital Data Solution Managers
SAP Quality Expert (BPO Regulatory Compliance)
3. Key relationship/customers
Global SAP S/4HANA and digital transformation project stakeholders
QMS team member
Functions and business units across manufacturing and distribution sites, and headquarters
Owners/users of interfacing systems (e.g., Polarion, Salesforce, eQMS platforms)
IT, Digital, and Data Governance teams
Key interfaces/liaison/functional guidance within the organization: Global Management Systems, Manufacturing/Operations, IT, Quality, Business Units, Sites, HQ
4. Key interfaces/functional guidance within ZEISS group
Identification of process gaps and definition of required changes within project timelines
Successful implementation and adoption of digital quality systems
Data integrity and compliance across systems
Efficiency improvements through digitalization and automation
Audit readiness and regulatory compliance
5. Key data / KPIs
Digital Quality Roadmap Delivery
SAP Quality Work Package Milestone Achievement
Global Process Harmonization Progress
eQMS, eDMS, RIMSYS Deployment and Adoption
Data Integrity Metrics
AI Solution Adoption and Effectiveness
Prompt Validation Compliance Rate
User Account (Li

Work arrangement
No