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Novartis Healthcare Pvt Ltd

Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health. Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stoc... Read More

Address      Sandoz House Shivsagar Estate Dr Annie Besant Road Worli, Mumbai India
Website      www.novartis.in/
Holding      No Holding Details

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APAC IT Quality Manager

Deliver Information Governance and Management (IGM) services to the assigned Novartis entities / IT units to ensure that information assets are adequately protected. Ensure that the quality of processes and deliverables of both projects and services assigned will continuously meet their specified corporate and regulatory requirements. Proactively work with respective IT Leadership Team and Business Stakeholders to implement standards and policies for Information Security, Governance and Management. Support the implementation and monitoring of the information security, IT compliance, records management and information risk management program in the assigned Novartis entities to ensure the integrity, confidentiality and availability of information owned, controlled or processed by the organization. Communicate and ensure compliance with Group security, risk management and compliance policies and standards. Work directly with the business units and functions to facilitate information risk management processes, identify acceptable levels of risk, and establish roles and responsibilities with regard to records management and information classification and protection. Provide compliance & risk management guidance for IT projects, including the evaluation and recommendation of technical controls. Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables. Coordinates documentation, testing, and change management activities in project and operations to ensure compliance with business and regulatory needs. Perform the PQM role for assigned IT projects (under regulated and non-regulated environments) including review and approval of major system documentation to ensure consistency with quality standards and quality of deliverables. Ensure that information governance & management programs are in compliance with applicable laws, regulations and policies to minimize or eliminate risk and audit findings. Liaise between the IT and local/functional compliance, audit, legal, data privacy, Health Safety and Environment (HSE) and QA functions as required. Ensure implementation of the information risk management process in the area of responsibility, including reporting and oversight of remediation/mitigation efforts to address negative findings. Monitor and report information risk status, trends & issues. Actively support training and awareness campaigns for associates. Distribute Novartis Policies and Standards to associates. Monitor IGM training needs and report needs for new support material, tool and templates. Escalate incidents and alerts to the IGM/ISEC Manager. Support the business with IGM/ISEC Risk Assessments. Gain awareness and report to IGM ISEC Manager the security incidents and events to protect information assets, including intellectual property, physical and the company's reputation. Coordinate the development of IT business continuity and IT disaster recovery plans and procedures to ensure that business-critical IT services are recovered in the event of a declared disaster, and provide direction and in-house consulting in these areas. Act as a regional resource manager for validation leads and specialists assigned to various projects or steady-state services. Desired Profile Bachelors degree in Engineering or Information Technology. Also Bachelors degree in Sciences may be considered. Master degree (MBA or MCA or MSc in sciences) Fluency (oral and written) in English, other languages an asset Minimally 6-8 years of overall experience with at least 5 years Computerized System Validation (CSV). Good understanding and knowledge of business processes in a global health care industry. Risk management or IT or security-related business background. Knowledge of general IT, project management and compliance domains. Good understanding of business processes and objectives. Good written and verbal communication and presentation skills. High level of customer focus with proven problem solving skills. Experience in audit management is advantageous for the job. Relevant certifications and/or presentations at key forums will be considered as an advantage. Experience 6 - 8 Years Industry Type Pharma / Biotech / Clinical Research Role Quality Assurance/Quality Control Manager

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