Sr. Spec. DDIT ISC QNova

Location: Hyderabad, India #LI-Hybrid (12 days/month in office)

Ensure effective and consistent implementation and operation of ISRM processes, methods, policies and tools in Function supporting all ISRM objectives and QA Computer Systems Validation for DDIT projects and systems operation

Deliver Quality management services to the NBS IT division and its Customers to ensure that information assets are adequately protected

MAJOR ACCOUNTABILITIES

1. Manages compliance of the system during its lifecycle, with regards to Regulatory and Novartis Internal Standards. This includes management of all system-related changes (approved documents, system changes from functional acceptance testing onwards). This is performed through document reviews & coordination of various activities including testing, performing Project Tollgates etc.

2. Provides compliance & risk management guidance for IT projects, including the evaluation and recommendation of technical controls. Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements, including creation of SOPs as applicable

3. Ensure implementation and monitoring of information security, IT compliance, records management and information risk management program in the DDIT, to ensure the integrity, confidentiality and availability of information owned, controlled or processed by the organization

4. Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.

5. Follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course.

6. Drive shifting of emphasis from "final inspections" to "in-process reviews and controls".Contribute to business decisions in the definition and assessment of IT requirements.

7. Support the development and delivery of training in quality matters. Interface with business and IT partners to ensure Novartis practices are aligned with regulatory expectations and industry best practices.

8. Supports Audits, Inspections and Assessments performed by internal and external agencies.Evaluates the risks arising from control deficiencies, gaps and facilitates risk mitigation planning

Essential Requirements:

• Good understanding and knowledge of business processes in a global health care industry
• Good knowledge of Project and Quality Management methodologies, (e.g. ICE, SDLC), Quality Systems and Policies
• 12+ years of working experience in IT Quality management / project management / service delivery positions in regulated environment / pharma / life sciences
• Experience working in GxP, CSV – Computerized system validation and 21 CFR Part 11 requirements
• Risk management background with experience in risk management related roles. Knowledge of General IT Software Engineering Life Cycle, project management and compliance domains.
• Experience working in diverse cultural environment and in a matrix organization
• Implementation of new processes or methodologies
• 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
• Familiar with compliance requirements (eg. SOX, FDA/GxP, GQO, COBIT, Records Management, Privacy, Legal, BCM/Disaster Recovery)

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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