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, apply now.
We are currently seeking a Portfolio Manager - Quality & Compliance Systems to join our team in Hyderabad, Telangana (IN-TG), India (IN).
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
Portfolio Management
Lead and govern a portfolio of Quality and Compliance Systems programs across multiple business units, sites, and regions.
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
- 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 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
Quality Management Systems
Electronic Quality Management Systems (eQMS)
Quality and Compliance Transformation
- CAPA
Deviations and Nonconformance Management
Change Control
Document Management
Training Management
Audit and Inspection Management
Complaints Management
Supplier Quality
Regulatory Compliance
Computer System Validation
Computer Software Assurance
Portfolio and Program Management
Vendor and Financial Management
Risk and Governance Management
Preferred Platform Experience
Experience with one or more of the following platforms is preferred:
Veeva Vault Quality
TrackWise Digital
Sparta TrackWise
MasterControl
ETQ Reliance
OpenText Documentum
Kneat Gx
ValGenesis
ComplianceWire
SAP Quality Management
ServiceNow GRC
Oracle Quality Management
Regulatory Information Management platforms
Preferred Certifications
PMP or PgMP
PMI Portfolio Management Professional (PfMP)
Certified Quality Auditor (CQA)
Certified Quality Engineer (CQE)
ASQ or RAC certification
SAFe Agilist or SAFe Program Consultant
ITIL Foundation
Lean Six Sigma Green Belt or Black Belt
Key Skills
Portfolio Management
Program Management
Quality Systems
Compliance Systems
eQMS
Digital Quality
- CAPA
Deviations
Change Control
Document Management
Audit Management
Training Management
Complaints Management
Supplier Quality
Life Sciences
Pharmaceutical Industry
Biotechnology
Medical Devices
GxP
FDA 21 CFR Part 11
EU Annex 11
- ISO 13485
ALCOA+
- CSA
Executive Stakeholder Management
Vendor Management
Budget Management
Risk and Governance
Digital Transformation
About NTT DATA
NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.
Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com, @nttdatafed.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, https://us.nttdata.com/en/contact-us.
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