Position summary :
Position in a global environment, 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, digital platforms (e.g., Polarion, Salesforce, Veeva, Trackwise, Dot Compliance).
The role focuses on defining, harmonizing, and optimizing business processes within a digital quality ecosystem, considering system interfaces, AI-driven solutions, and data governance across multiple manufacturing and distribution sites as well as headquarters.
Primary duties and responsibilities :
- Actively participate in all activities required for the implementation of digital 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 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.
AI & Digital Quality Innovation
- Identify and drive opportunities for AI-enabled quality improvements (e.g., automation, predictive quality, AI agents)
- Support the creation, training, and deployment of AI agents to enhance quality processes and decision-making
- Ensure AI-based solutions comply with regulatory and quality requirements
- Contribute to continuous improvement and innovation within the digital quality landscape .
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.
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 requirements
- Create and maintain QMS documentation (procedures, work instructions, digital process documentation) required for compliance and successful system implementation
- Ensure alignment of digital systems with regulatory requirements (e.g., ISO 13485, MDR, GxP, FDA 21 CFR)
- Support QMS team in additional quality-related activities as required by line management.
Education / Professional Certification
- Academic degree (Bachelor or higher) in Quality Management, Engineering, IT, Life Sciences, Business Administration, or a related field.
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., Polarion, TrackWise, Master Control, or similar)
- Minimum 3–5 years of experience in regulated Quality Management Systems (ISO 13485 preferred)
- Experience in SAP S/4HANA implementation preferred
- Exposure to AI, automation, or digital innovation projects is an advantage
Knowledge / Skills / Other characteristics
- 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, and data lifecycle management
- Familiarity with AI concepts, including AI agent creation and training
- 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
