Portfolio Manager - Quality & Compliance Systems

NTT DATA BUSINESS SOLUTIONS

Hyderabad

Hybrid

INR 3,000,000 - 6,500,000

Full time

14 days+

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Job summary

NTT DATA BUSINESS SOLUTIONS seeks a seasoned Portfolio Manager to lead Quality and Compliance Systems programs across global sites in a remote/hybrid setup. You will drive strategy, governance, and execution for eQMS, regulatory information management, and CAPA initiatives.

The role requires 12+ years in life sciences IT/quality programs, cross-functional leadership, and experience with validated systems in regulated environments.

Qualifications

Bachelor's degree in Life Sciences or a related discipline.
12+ years of experience in IT, Quality Systems, Digital Transformation, or Program Management.
5+ years of experience managing enterprise portfolios or large-scale programs involving Quality and Compliance Systems.
5+ years of experience in Pharmaceutical, Biotechnology, Medical Devices, Healthcare, or Life Sciences industries.
5+ years of global, multi-site quality transformation leadership.

Responsibilities

Lead and govern a portfolio of Quality and Compliance Systems programs across units, sites, and regions.
Define portfolio strategy, roadmap, budgets, resources, and investments.
Monitor portfolio health, milestones, risks, and value realization.
Establish governance, dashboards, KPIs, and standardized reporting.
Oversee end-to-end project delivery, validation, testing, and operational transition.
Coordinate cross-functional teams, vendors, and system integrators.
Drive digital transformation across enterprise quality processes and platforms.

Skills

Portfolio Management

Quality Systems

Regulatory Compliance

Stakeholder Management

Vendor Management

Risk & Governance

Education

Bachelor's degree in Life Sciences, Quality Management, Information Technology, Engineering, Computer Science, or a related discipline

Tools

Veeva Vault Quality

TrackWise Digital

MasterControl

SAP Quality Management

Regulatory Information Management platforms

OpenText Documentum

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 RD 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 Portfolio Management

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, RD, 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 vendors, consulting partners, system integrators, and managed service providers.
Manage contracts, statements of work, vendor performance, deliverables, and service-level commitments.
Track portfolio benefits, cost savings, compliance improvements, and return on investment.

Required Qualifications

Bachelor's degree in Life Sciences, Quality Management, Information Technology, Engineering, Computer Science, or a related discipline.
12+ years of experience in IT, Quality Systems, Digital Transformation, or Program Management.
5+ years of experience managing enterprise portfolios or large-scale programs involving Quality and Compliance Systems.
5+ years of strong experience within the Pharmaceutical, Biotechnology, Medical Devices, Healthcare, or broader Life Sciences industry.
5+ years of proven experience leading global, multi-site quality transformation programs.
5+ years of demonstrated experience managing executive stakeholders, cross-functional teams, vendors, and implementation partners.
5+ years of strong understanding of regulated system delivery and validation lifecycle requirements.

Required Technical and Functional Expertise