Snr. Spec. Ddit Isc Qnova

3 weeks ago

Hyderabad District Telangana, India Novartis Full time

Location : #L1 Hybrid
A proven compliance expert with strong people and service management skills. The Project Quality Manager will ensure alignment and adherence across the IT, business, service provider and other stakeholders on quality and compliance for the IT projects. Deliver Quality management services to the NBS IT division and its Customers to ensure that information assets are adequately protected and compliant.
Your responsibilities include, but are not limited to:

- Perform validation impact analysis and risk assessments, both high level and functional, to ensure requirements coverage.
- Author key validation deliverables, provide GxP related validation expertise and partner with key business stakeholders (i.e. Manufacturing, Quality, Validation, Risk and Compliance, etc.) in defining the CSV strategy.
- Should be thorough with Document Management processes i.e. create, review, update and approve CSV deliverables including Validation Assessment, Validation Plan, Test Plan, Qualification scripts (IQ, OQ, PQ), Test protocols and reports, Traceability Matrix and Validation Summary Report.
- Experience of SDLC (Waterfall or Agile methodologies or DevOPS) and responsible for tracking, monitoring and controlling validation process to ensure timely and cost-effective delivery of the system to the business users.
- Provides compliance & risk management guidance for IT projects, including the evaluation, implementation and monitoring of information security controls.
- Ensure implementation and monitoring of IT compliance, records management and information risk management during IT projects, to ensure the integrity, confidentiality and availability of information owned, controlled or processed by the organization.
- Interface with business and IT partners to ensure Novartis practices are aligned with regulatory expectations and industry best practices.
- Supports Audits, Inspections and Assessments performed by internal and external agencies.
- Evaluates the risks arising from control deficiencies, gaps and facilitates risk mitigation planning
- First point of contact for all quality related queries on the projects, follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- 8+ years of working experience in IT Quality management / Information Security and Risk management / service delivery positions in regulated environment / pharma / life sciences
- Bachelor’s degree in Engineering/ Sciences or relevant technical experience.
- Knowledge on Waterfall, Agile and DevOps methodology.
- Familiar with compliance requirements (e.g. SOX, FDA/GxP, GQO, COBIT, Records Management, Privacy, Legal, BCM/Disaster Recovery).

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
**Division**

Operations

**Business Unit**

DATA, DIGITAL & IT

**Country**

India

**Work Location**

Hyderabad, AP

**Company/Legal Entity**

Nov Hltcr Shared Services Ind

**Functional Area**

Technology Transformation

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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