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Novo Nordisk
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Lead IT Validation & Compliance

Lead IT Validation & Compliance

Novo Nordisk

15 - 20 years

13 - 17 Lacs

bengaluru

Posted:None| Platform:

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Skills Required

risk assessment project management regulatory compliance change management regulatory requirements pharmaceutical data validation regulatory system validation it compliance process validation it systems quality assurance life sciences gxp

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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Novo Nordisk

Pharmaceutical Manufacturing

Bagsværd Kalundborg

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Lead IT Validation & Compliance