05 Oct
|
QAAgility Technologies
|
India
05 Oct
QAAgility Technologies
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,knwoledge on ServiceNow n 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 & Product Teams to ensure the solutions are designed in compliance with IT&Q; requirements.
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
Solid 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 & Data Platform Understanding
Cloud-based platforms
Data pipelines & analytics
AI / Data Science lifecycle (emerging area referenced in IT&Q;)
Information Security & Data Integrity
Understanding of security controls in IT solutions
Familiarity with data integrity principles (especially in regulated environments)
Governance & Lifecycle Management
Experience in IT system lifecycle governance (V-model or equivalent) 1
Ability to ensure compliance across build–run–change phases
Stakeholder Management & Influence
Strong communication skills to translate compliance into practical guidance
Ability to collaborate across product, engineering, and quality teams
Documentation & Audit Mindset
Strong attention to detail in documentation
Experience supporting audits or inspections
Optional Skills
SW Quality
Working in agile teams
Roles & Responsibilities
- IT&Q; Compliance Framework & SOP Alignment
Ensure adherence to relevant IT&Q; procedures and instructions for digital solutions and IT systems.
Interpret and apply IT SOPs such as:
Manage IT systems incl. digital solutions (Q187219)
Manage Information Security in IT Solutions (Q187655)
Manage Data Integrity in IT (Q204010) (where applicable)
Guide teams on how to use procedures, guidelines, and templates appropriately (mandatory vs. supporting).
- Risk Management & Compliance by Design
Lead and facilitate IT risk assessments using ServiceNow IRM to identify required controls early in solution development.
Ensure risk-based approach is applied (compliance effort proportional to solution criticality).
Define and monitor mitigation actions and control implementation.
- Governance of Digital Solutions & Platforms
Ensure proper compliance governance across:
System lifecycle (design, build, validation, release, operations)
Data pipelines and analytics platforms
Support system owners and product teams in meeting IT ownership and governance expectations.
- Information Security & Data Integrity
Ensure compliance with information security controls embedded in design and operations.
Drive implementation of data integrity principles (especially for GxP-relevant solutions).
Collaborate with Global Information Security and Privacy stakeholders where needed.
- Documentation & Audit Readiness
Ensure required documentation is defined, created, and maintained:
SOP-aligned deliverables
Risk assessments
Validation and operational records
Leverage IT&Q; templates and toolkit for standardization.
Support audits and inspections by ensuring traceability and compliance evidence.
- Enablement & Stakeholder Support
Act as a trusted advisor to product owners, engineers, and architects.
Train and guide teams on IT&Q; processes, templates, and expectations.
Promote adoption of
IT&Q; toolkit
Supporting solutions (ServiceNow ITSM / IRM / ITOM)
- Optimization via Pass List & Standard Platforms
Guide teams in using approved platforms (Pass List) to reduce compliance effort.
Identify opportunities to simplify compliance through standardized solutions.
📌 System Manager - IT and quality Compliance Management- Remote (India)
🏢 QAAgility Technologies
📍 India