IT Compliance Optimization

IT Compliance Optimization & Digitalization

**Category**:Digital & IT**Location**:Bangalore, Karnataka, IN**Department Name - **xDD&IT Services GBS-
**About the department**
- CVT CoE is the unit responsible for supporting compliance management of multiple IT systems in Novo Nordisk. The systems are used on a global scale by many areas of the business, including R&D, PSQ etc. and are critical to the execution of key business process such as development, manufacturing, sales, finance etc. CVT CoE focuses on delivering harmonized support services related in the Compliance, Validation and Testing areas, thus supporting the maintenance of the systems in a validated state.**The Position**

**As an IT Compliance Digitalization and Automation, your primary responsibility shall be**:

- Identify opportunities for digitalization and automation across various functions and processes within the organization. Develop and implement digital strategies to streamline workflows, improve efficiency, and enhance data management. Collaborate with IT teams to evaluate, select, and implement digital tools and technologies to support digital transformation initiatives.
- Ensure the security and integrity of digital systems, data, and processes. Conduct regular assessments to identify bottlenecks, inefficiencies, and areas for process optimization. Drive process simplification/digitalization journey.
- Liaise with stakeholders on innovative culture and harness knowledge across GBS and DK. Work closely with Internal and External Stakeholders. Presenting and hosting workshops to promote a digitalisation mindset. Ensure that IT processes are following relevant internal and external requirements.
- Develop the overall digital transformation strategy and specific plan(s) for the full lifecycle of technical implementation and new technology initiatives. Manage the entire work plan for the digital transition, provide weekly status reports, locate problems, and control risks. Establish and maintain communication with key customer decision-makers; lead and coordinate pursuit teams. Conduct assessments on performance, change readiness of the business area to simplify/digitalize or automate IT processes. Present IT process simplification/digitalization/automation proposals to stakeholders. Work closely with Process Office and Quality to drive process simplification/digitalization updates to SOPs.
- Work with OCM consultants or change agents to drive trainings and adoption of the updated IT processes as a result of IT process simplification/digitalization/automation. Ensure regulatory requirements are met and systems, solutions are audit ready. Support audits and inspections, as well as support closure of actions, if applicable. Stay up to date with emerging technologies and industry best practices related to technology and automation. Evaluate and recommend the adoption of new tools to optimise IT operations. Ensure data governance, security measures, quality, and integrity within automated operations.

**Qualifications**
- Master’s degree or relevant technology experience with high level technical certifications (Software Engineering, Computer Science, Business Administration).
- 10+ years of experience working within IT.
- 6-7 years of experience in CSV, regulatory compliance in pharmaceutical industry.
- Good understanding of GAMP 5 Guide (GAMP 5) and various Regulatory requirements including CFR part 11, EU Annex 11.
- Experienced in proposing and implementing process improvements/simplification or digitalization/automation.
- ITIL processes especially Change, Release and Configuration management.
- Experience with working with Agile framework.
- Good interpersonal, communication and presentation skills.
- Ability to represent NN in relations with internal and external stakeholders including Suppliers and Authorities.
- Self-managed, strong personal drive with coaching skills to motivate employees, colleagues and peers towards delivering excellent performance and results including continuous improvement.
- Ability to analyse and solve complex issues in a timely and structured manner.
- Ability to collaborate and communicate with stakeholders, both internal and external at all levels.
- High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.

**Working at Novo Nordisk**
- Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working towards something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life chan