BENGALURU · FULLTIME
Digital Solution Manager
Zexen Pharmaceuticals
Bengaluru · onsite · Posted 26d ago
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Undisclosed3–5 yrsfulltimeBengaluru
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Section · 01
About this role
ZEISS in India
ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports Cine Optics.
ZEISS India has 3 production facilities, RD center, Global IT services and about 40 Sales Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS success story in India is continuing at a rapid pace.
Further information at ZEISS India .
Purpose of this position / 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 (eg, Polarion, Salesforce, Veeva, Trackwise, DotCompliance).
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
Digital Transformation
- 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 (eg, 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 (eg, ISO 13485, MDR, GxP, FDA 21 CFR)
- Support QMS team in additional quality-related activities as required by line management
Education requirements / Experience / Job Specifications
- State the minimum qualifications required to successfully perform the job. These qualifications that are necessary for someone to be considered for the position.All qualifications must comply with provincial human rights legislation.
Education / Professional Certification
- Academic degree (Bachelor or higher) in Quality Management, Engineering, IT, Life Sciences, Business Administration, or a related fieldundefined2.
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 (eg, Polarion, TrackWise, MasterControl, or similar)Minimum 3-5 years of experience in regulated Quality Management Systems (ISO 13485 preferred)Experience in SAP S/4HANA implementation preferredExposure to AI, automation, or digital innovation projects is an advantageundefined
Knowledge / Skills / Other characteristics
- Language: Fluent in English (spoken and written); German is a plusStrong experience with SAP S/4HANA, particularly in manufacturing environmentsExperience in integrating multiple digital systems and managing interfacesKnowledge of Quality Management Systems and regulatory frameworks (ISO 13485, MDR, GxP, FDA 21 CFR)Knowledge of quality tools and methods (eg, CAPA, incoming inspection, recalls, quarantine, control plans)Experience in data governance, data structures, and data lifecycle managementFamiliarity with AI concepts, including AI agent creation and trainingExperience in mapping complex business processes in high-volume, regulated environmentsExperience in business process improvement (Six Sigma is a plus)Strong analytical skills with the ability to derive conclusions from incomplete or ambiguous informationProven ability to work independently with excellent communication and organizational skillsProven ability to troubleshoot digital system implementation issuesundefined
Your ZEISS Recruiting Team:
Itishree PaniDisclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Section · 02
Skills
AutomationCfranalytical thinkingISO 13485business processdigital platformsCAPAData StructuresdeploymentDigital TransformationData GovernanceAdministrationIT Servicescomplianceincoming inspectionLife SciencesArtificial Intelligence
Section · Company
About Zexen Pharmaceuticals
Zexen Pharmaceuticals
₹6.4L PA avg
Avg at Zexen Pharmaceuticals
About
Zeiss Pharma Ltd., where we are dedicated to improving global health by providing high-quality, affordable medicines. Founded in 2005, we have rapidly grown to become a leading manufacturer of Cephalosporins and Carbapenems in Asia. Our manufacturing facilities
Industries
Healthcare / Pharma
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