Website:
zeiss.co.in
Job details:
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 (Licence) in use, not in use
- Quality Automation Benefit Realization
- Digital Audit Readiness
- User Adoption and Training Effectiveness
- System Standardization Metrics
Education / Professional Certification
- Academic degree (Bachelor or higher) in Quality Management, Engineering, IT, Life Sciences, Business Administration, or a related field
2. Experience
- 5+ years of experience in digital quality, SAP S/4HANA, or eQMS implementation in a global environment
- Experience as SAP superuser, especially in QM-related processes
- Experience with eQMS platforms (e.g., VEEVA, Trackwise, or similar)
- Experience with RIM platforms (e.g. IQVIA; RIMSYS)
- Experience to connect automated processes (IT + OT)1 to other systems and operations and leverage collective analytics and learnings to continuously improve system autonomy
- Minimum 3–5 years of experience in regulated Quality Management Systems (ISO 13485 preferred)
- Experience to define and implement AI Agents (CoPilot), automation, or digital innovation projects is an ad-vantage
3. Knowledge / Skills / Other characteristics
- Language: Fluent in English (spoken and written); German is a plus
- Strong experience with SAP S/4HANA, particularly in manufacturing environments
- Experience in integrating multiple digital systems and managing interfaces
- Knowledge of Quality Management Systems and regulatory frameworks (ISO 13485, MDR, GxP, FDA 21 CFR)
- Knowledge of quality tools and methods (e.g., CAPA, incoming inspection, recalls, quarantine, control plans)
- Experience in data governance, data structures, data lifecycle management, and analytics-driven decision making
- Knowledge of AI concepts, including AI agent creation, Prompt Engineering, and AI Governance frameworks
- Experience in mapping complex business processes in high-volume, regulated environments
- Experience in business process improvement (Six Sigma is a plus)
- Strong analytical skills with the ability to derive conclusions from incomplete or ambiguous information
- Proven ability to work independently with excellent communication and organizational skills
- Proven ability to troubleshoot digital system implementation issues
- Experience in Digital Transformation, Digital Strategy Development, and governance of digital platforms and
- enterprise applications
- Experience in business ownership of enterprise quality systems
- Strong stakeholder management and influence leadership skills
- Experience in portfolio management and prioritization within global organizations
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