Portfolio Manager - Quality & Compliance Systems

NTT DATA, Inc.; Hyderabad; Hybrid; INR 2,500,000 - 6,000,000; Full time

Job summary

NTT DATA, Inc. in Hyderabad, India, is seeking an experienced Portfolio Manager to lead Quality & Compliance Systems across Life Sciences.

The role focuses on managing enterprise-wide quality transformation programs, regulatory compliance initiatives, and digital quality platforms supporting pharma, biotech, medical devices, and lab operations. The ideal candidate will bring deep experience in Quality and Compliance technology portfolios within regulated environments, coordinating with QA,

Qualifications

• 12+ years of experience in Life Sciences quality and compliance programs.
• Experience leading large, multi-project portfolios with strategic impact.
• Strong collaboration with QA, Regulatory Affairs, Manufacturing, IT and external partners.

Responsibilities

• Lead and govern a portfolio of Quality and Compliance Systems programs across sites and regions.
• Define portfolio strategy, roadmap, budgets, resources and investment needs.
• Monitor portfolio health, milestones, risks, dependencies, and value realization.
• Establish governance, dashboards, KPIs and standardized reporting.
• Ensure alignment with regulatory requirements and enterprise architecture.

Skills

Portfolio management

Quality systems

Compliance management

Stakeholder management

Regulatory coordination

Tools

eQMS

Document Management Systems

LMS

Regulatory Information Management

Job description

Portfolio Manager - Quality & Compliance Systems

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization

We are currently seeking a Portfolio Manager - Quality & Compliance Systems to join our team in Hyderabad, Telangana (IN-TG), India (IN).

Job Description: Portfolio Manager – Quality & Compliance Systems (Life Sciences)

Job Title - Portfolio Manager – Quality & Compliance Systems

Experience: 12+ Years
Location: Remote/Hybrid (Travel as Required)

Project Overview

We are seeking an experienced Portfolio Manager to lead a portfolio of strategic Quality and Compliance Systems initiatives within a global Life Sciences organization. This role will be responsible for managing enterprise-wide quality transformation programs, regulatory compliance initiatives, and digital quality platforms that support Pharmaceutical, Biotechnology, Medical Devices, Manufacturing, Laboratory, and R&D operations.

The ideal candidate will have strong experience managing complex quality and compliance technology portfolios in regulated environments. This role requires close collaboration with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, IT, Validation, Audit, and external implementation partners to deliver compliant, scalable, and business-aligned solutions.

Key Responsibilities

• Lead and govern a portfolio of Quality and Compliance Systems programs across multiple business units, sites, and regions.
• Define portfolio strategy, roadmap, priorities, budgets, resource plans, and investment requirements.
• Monitor portfolio health, delivery milestones, risks, dependencies, financial performance, and value realization.
• Establish governance frameworks, executive dashboards, KPIs, and standardized reporting.
• Ensure alignment of quality technology initiatives with business objectives, regulatory requirements, and enterprise architecture.

Program and Project Leadership

• Manage multiple concurrent quality system implementations, upgrades, migrations, integrations, and modernization initiatives.
• Oversee end-to-end project delivery, including planning, design, configuration, validation, testing, deployment, hypercare, and operational transition.
• Coordinate cross-functional teams, business process owners, vendors, system integrators, and technical teams.
• Identify and resolve cross-program risks, dependencies, resource conflicts, and delivery challenges.
• Ensure projects are delivered within agreed scope, schedule, budget, and quality expectations.

Quality Systems Transformation

• Lead digital transformation initiatives across enterprise quality processes and platforms.
• Manage programs involving:
• Electronic Quality Management Systems (eQMS)
• Document Management Systems
• Learning Management Systems
• Regulatory Information Management Systems
• Audit and Inspection Management
• Corrective and Preventive Action (CAPA)
• Deviations and Nonconformance Management
• Change Control
• Complaints Management
• Supplier Quality Management
• Training and Compliance Management
• Drive process standardization, harmonization, automation, and continuous improvement across global quality operations.

Compliance and Validation

• Ensure systems and solutions comply with applicable Life Sciences regulations and quality standards, including:
• GxP
• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• ISO 13485
• ALCOA+ data integrity principles
• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• Ensure appropriate validation, traceability, documentation, and quality oversight throughout the system lifecycle.
• Support regulatory inspections, internal audits, external audits, and remediation activities.
• Ensure systems remain compliant, secure, audit-ready, and fit for intended use.

Business and Stakeholder Management

• Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, R&D, Supply Chain, IT, and business leadership.
• Facilitate portfolio governance and executive steering committee meetings.
• Provide clear executive-level updates on portfolio status, financials, risks, decisions, and business outcomes.
• Collaborate with global process owners to prioritize initiatives and define transformation roadmaps.
• Drive organizational change management, communications, training, and adoption.

Financial and Vendor Management

• Manage portfolio budgets, forecasts, resource allocation, and financial reporting.
• Oversee software