NTT DATA North America
Website:
us.nttdata.com
Company:
https://www.linkedin.com/company/ntt-data-americas
Seniority: Mid-Senior level
Industries: IT Services and IT Consulting
Job details:
Req ID: 384500
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 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
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, 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
- GAMP 5
- ISO 13485
- ALCOA+
- CSV
- 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.
NTT DATA endeavors to make https://us.nttdata.com accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at https://us.nttdata.com/en/contact-us. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.
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