Lead IT Validation

2 days ago

Bengaluru, Karnataka, India Novo Nordisk Full time US$ 1,50,000 - US$ 2,00,000 per year

Novo Nordisk Global Business Services (GBS) India

Department Commercial DD&IT, GBS

Are you passionate about IT validation and compliance? Do you want to play a pivotal role in ensuring regulatory adherence and driving innovation in a global pharmaceutical company? If you have the expertise and enthusiasm to lead in this critical area, we want to hear from you Read on and apply today.

The position

As a Lead IT Validation & Compliance at Novo Nordisk, you will be entrusted with the following responsibilities:

  • Ensure IT compliance by monitoring adherence to regulations like GDPR and GxP, aligning systems with evolving standards, and enforcing internal policies.
  • Lead IT system validation by managing the full lifecyclefrom planning to reportingand ensuring compliance through development and review of validation protocols and documentation.
  • Develop and maintain IT compliance frameworks by creating policies, procedures, and documentation, while ensuring accurate records for audits and inspections.
  • Collaborate with cross-functional teams to identify and mitigate compliance risks, while providing guidance and training on best practices and regulatory requirements.
  • Conduct audits and assessments of IT systems to evaluate compliance, identify gaps, recommend corrective actions, and ensure continuous improvement.

Qualifications

  • Bachelors degree in computer science, Information Technology, or a related field, with a total of 15+ years of experience, including 10+ years in IT compliance, validation, or quality assurance within a regulated industry, preferably pharmaceuticals or life sciences.
  • Must have extensive knowledge of GxP, regulatory requirements, and IT system validation processes.
  • Demonstrated expertise in leading compliance initiatives and fostering cross-functional collaboration.
  • Strong experience in regulatory compliance, validation processes, risk assessment, IT systems, change management, stakeholder collaboration, continuous improvement, project management, and analytical problem-solving.
  • Strong interpersonal, analytical, communication, and collaboration skills, with the ability to represent Novo Nordisk in interactions with users and external stakeholders.

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