IT Quality & Compliance Manager (India)

Role : IT and Quality Compliance Management System Manager.

Work mode : Remote.

Experience : 8 - 12 years.

Mandatory skills : IT Security, GXP control, risk assessment, pharma exposure, understand the operations, knowledge on ServiceNow and Veeva Vault.

Main technology : The IT&Q; Compliance Manager ensures that all digital solutions and data platforms are designed, developed, and operated in accordance with IT&Q; requirements, applicable SOPs, and regulatory expectations.

The role focuses on embedding compliance-by-design, enabling risk-based decision-making, and ensuring that IT solutions meet required standards depending on criticality and risk exposure.

The Compliance Manager will be active and consulted by IT System Owners and Product Teams to ensure the solutions are designed in compliance with IT&Q; requirements.

Tech Stack

• ServiceNow (IRM, ITSM, ITOM)
• IT&Q; Toolkit and templates
• QualityDocs (for SOPs)
• Collaboration platforms (e.g., SharePoint, Teams)

Must Have Skills

• Must have supported at least 1 - 2 GxP or Business Critical Systems in Novo Nordisk.
• Experience in regulated IT environments Pharma GXP.
• IT&Q; Process Expertise.
• Robust understanding of IT&Q; procedures, instructions, and SOP structure.
• Ability to interpret regulatory and internal requirements into actionable guidance.
• Risk-Based Thinking.
• Ability to assess IT risks and define proportional controls.
• Hands-on experience with IT risk assessments (e.g., ServiceNow IRM).
• Digital and Data Platform Understanding.
• Cloud-based platforms.
• Data pipelines and analytics.
• AI / Data Science lifecycle (emerging area referenced in IT&Q;).
• Information Security and Data Integrity.
• Understanding of security controls in IT solutions.
• Familiarity with data integrity principles (especially in regulated environments).
• Governance and Lifecycle Management.
• Experience in IT system lifecycle governance (V-model or equivalent).
• Ability to ensure compliance across build-run-change phases.
• Stakeholder Management and Influence.
• Strong communication skills to translate compliance into practical guidance.
• Ability to collaborate across product, engineering, and quality teams.
• Documentation and Audit Mindset.
• Strong attention to detail in documentation.
• Experience supporting audits or inspections.

Optional Skills

• SW Quality.
• Working in agile teams.

Roles And Responsibilities

• Ensure adherence to relevant IT&Q; procedures and instructions for digital solutions and IT systems.
• Lead and facilitate IT risk assessments using ServiceNow IRM to identify required controls early in solution development.
• Ensure proper compliance governance across system lifecycle (design, build, validation, release, operations).
• Ensure compliance with information security controls embedded in design and operations.
• Ensure required documentation is defined, created, and maintained.
• Act as a trusted advisor to product owners, engineers, and architects.
• Guide teams in using approved platforms (Pass List) to reduce compliance effort.

(ref:hirist.tech)