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Responsibilities
Project OverviewWe 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 ResponsibilitiesPortfolio ManagementLead 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 LeadershipManage 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 withedule, budget, and quality expectations.Quality Systems TransformationLead digital transformation initiatives across enterprise quality processes and platforms.Manage programs involving:Electronic Quality Management Systems (eQMS)Document Management SystemsLearning Management SystemsRegulatory Information Management SystemsAudit and Inspection ManagementCorrective and Preventive Action (CAPA)Deviations and Nonconformance ManagementChange ControlComplaints ManagementSupplier Quality ManagementTraining and Compliance ManagementDrive process standardization, harmonization, automation, and continuous improvement across global quality operations.Compliance and ValidationEnsure systems and solutions comply with applicable Life Sciences regulations and quality standards, including:GxPFDA 21 CFR Part 11EU Annex 11GAMP 5ISO 13485ALCOA+ data integrity principlesComputer 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 remaure, audit-ready, and fit for intended use.Business and Stakeholder ManagementPartner 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 ManagementManage 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 QualificationsBachelor's degree lity Management, Information Technology, Engineering, Computer Science, or a related discipline.12+ years of experience lity 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 withtechnology, 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 ExpertiseQuality Management SystemsElectronic Quality Management Systems (eQMS)Quality and Compliance TransformationCAPADeviations and Nonconformance ManagementChange ControlDocument ManagementTraining ManagementAudit and Inspection ManagementComplaints ManagementSupplier QualityRegulatory ComplianceComputer System ValidationComputer Software AssurancePortfolio and Program ManagementVendor and Financial ManagementRisk and Governance ManagementPreferred Platform ExperienceExperience with one or more of the following platforms is preferred:Veeva Vault QualityTrackWise DigitalSparta TrackWiseMasterControlETQ RelianceOpenText DocumentumKneat GxValGenesisComplianceWireSAP Quality ManagementServiceNow GRCOracle Quality ManagementRegulatory Information Management platformsPreferred CertificationsPMP or PgMPPMI Portfolio Management Professional (PfMP)Certified Quality Auditor (CQA)Certified Quality Engineer (CQE)ASQ or RAC certificationSAFe Agilist or SAFe Program ConsultantITIL FoundationLean Six Sigma Green Belt or Black BeltKey SkillsPortfolio ManagementProgram ManagementQuality SystemsCompliance SystemseQMSDigital QualityCAPADeviationsChange ControlDocument ManagementAudit ManagementTraining ManagementComplaints ManagementSupplier QualityLife SciencesPharmaceutical IndustryBiotechnologyMedical DevicesGxPFDA 21 CFR Part 11EU Annex 11GAMP 5ISO 13485ALCOA+CSVCSAExecutive Stakeholder ManagementVendor ManagementBudget ManagementRisk and GovernanceDigital TransformationAbout NTT DATANTT 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 ud, 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 RD.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.
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