Project Program Mgmt. Specialist Advisor
NTT America, Inc.
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Descripción de la vacante
NTT DATA is seeking an experienced Program Manager to lead strategic Quality and Compliance Systems initiatives within a global Life Sciences organization. You will oversee complex, enterprise-wide programs involving QMS implementations, document management, training, audit management, and regulatory compliance across multiple sites.
The ideal candidate has 10–15+ years in IT, Quality Systems, or Program Management and a track record of delivering large-scale quality technology programs in
Formación
- Bachelor’s degree in Life Sciences, Quality Management, IT, Engineering, Computer Science, or a related discipline.
- 10–15+ years of experience in IT, Quality Systems, Digital Transformation, Validation, or Program Management.
- At least 5 years of experience managing large Quality and Compliance Systems programs.
- 5+ years of experience in the Pharmaceutical, Biotechnology, Medical Devices, or Life Sciences industry.
- 5+ years of proven experience leading global or multi-site quality technology initiatives.
- 5+ years of demonstrated ability to manage complex programs involving Quality, Regulatory, IT, Validation, and vendor teams.
Responsabilidades
- Lead end-to-end delivery of Quality and Compliance Systems programs across multiple business units, functions, and global sites.
- Define program objectives, scope, roadmap, governance, milestones, and success criteria.
- Manage multiple related projects, workstreams, and cross-functional dependencies.
- Establish executive governance, decision-making forums, escalation mechanisms, and reporting standards.
- Ensure program outcomes align with enterprise quality strategy, regulatory expectations, and business objectives.
- Drive process standardization, harmonization, and automation across global quality operations.
- Support integration of quality platforms with ERP, MES, LIMS, CRM, HR, data platforms, and other enterprise systems.
Conocimientos
Educación
Herramientas
Descripción del empleo
Req ID: 386114
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 Project Program Mgmt. Specialist Advisor to join our team in GDL, Jalisco (MX-JAL), Mexico (MX).
We are seeking an experienced Program Manager to lead strategic Quality and Compliance Systems initiatives within a global Life Sciences organization.
The Program Manager will be responsible for delivering complex, enterprise-wide programs involving quality system implementation, modernization, integration, validation, remediation, and business adoption. The role will oversee multiple related projects across areas such as electronic Quality Management Systems, document management, training, audit management, regulatory compliance, and validation platforms.
The ideal candidate will have strong experience managing global quality technology programs in highly regulated Life Sciences environments and working closely with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, R&D, IT, Validation, Audit, and external implementation partners.
- Lead end-to-end delivery of Quality and Compliance Systems programs across multiple business units, functions, and global sites.
- Define program objectives, scope, roadmap, governance, milestones, and success criteria.
- Manage multiple related projects, workstreams, and cross-functional dependencies.
- Establish executive governance, decision-making forums, escalation mechanisms, and reporting standards.
- Ensure program outcomes align with enterprise quality strategy, regulatory expectations, and business objectives.
- Lead implementation, upgrade, migration, integration, and optimization of enterprise quality platforms.
- Manage programs involving:
- Electronic Quality Management Systems
- Document Management Systems
- Learning and Training Management Systems
- CAPA Management
- Deviations and Nonconformance Management
- Change Control
- Audit and Inspection Management
- Complaints Management
- Supplier Quality Management
- Regulatory Information Management
- Validation Management
- Drive process standardization, harmonization, and automation across global quality operations.
- Support integration of quality platforms with ERP, MES, LIMS, CRM, HR, data platforms, and other enterprise systems.
- Develop and maintain integrated program plans, schedules, budgets, resource plans, and delivery forecasts.
- Track milestones, critical paths, risks, issues, assumptions, dependencies, and decisions.
- Coordinate business, functional, technical, validation, infrastructure, cybersecurity, data, and vendor teams.
- Ensure timely completion of design, configuration, integration, testing, validation, deployment, cutover, and hypercare activities.
- Manage scope, priorities, and changes through formal governance and change-control processes.
- Ensure program delivery complies 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
- Computer Software Assurance
- Partner with Quality and Validation teams to ensure proper documentation, traceability, testing, approvals, and evidence.
- Support regulatory inspections, internal audits, external audits, and remediation programs.
- Ensure systems remain validated, secure, audit-ready, and fit for intended use throughout their lifecycle.
- Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, R&D, Supply Chain, IT, and executive leadership.
- Facilitate steering committee meetings, governance reviews, and executive status discussions.
- Provide clear reporting on program health, financials, risks, decisions, and business outcomes.
- Build alignment across global process owners, site leadership, technology teams, and vendors.
- Resolve conflicts and manage expectations across business, quality, and technical stakeholders.
- Proactively identify and manage regulatory, business, technical, operational, and delivery risks.
- Develop mitigation and contingency plans for critical risks and dependencies.
- Escalate material issues and decisions through appropriate governance forums.
- Coordinate remediation activities and corrective actions when program delivery or compliance is at risk.
- Manage program budgets, forecasts, purchase orders, contracts, and financial performance.
- Oversee software vendors, system integrators, consulting partners, and managed service providers.
- Monitor vendor milestones, deliverables, quality, service levels, and contractual commitments.
- Manage Statements of Work, resource capacity, commercial dependencies, and change requests.
- Track program benefits, compliance improvements, operational efficiencies, and value realization.
- Lead organizational readiness, stakeholder communication, training, and user-adoption activities.
- Coordinate business process changes, deployment readiness, cutover, and hypercare.
- Partner with Quality and business process owners to ensure new systems and processes are successfully adopted.
- Support transition from program delivery to production support and steady-state operations.
- Measure adoption, user satisfaction, and continuous-improvement opportunities.
- Bachelor’s degree in Life Sciences, Quality Management, Information Technology, Engineering, Computer Science, or a related discipline.
- 10-15+ years of experience in IT, Quality Systems, Digital Transformation, Validation, or Program Management.
- At least 5 years of experience managing large Quality and Compliance Systems programs.
- 5+ years of strong experience in the Pharmaceutical, Biotechnology, Medical Devices, or broader Life Sciences industry.
- 5+ years of proven experience leading global or multi-site quality technology initiatives.
- 5+ years of demonstrated ability to manage complex programs involving Quality, Regulatory, IT, Validation, and vendor teams.
- 5+ years of strong understanding of regulated system delivery and lifecycle management.
- Quality Management Systems
- Electronic Quality Management Systems
- Digital Quality Transformation
- CAPA
- Deviations and Nonconformance Management
- Change Control
- Document Management
- Training Management
- Audit and Inspection Management
- Complaints Management
- Supplier Quality Management
- Regulatory Compliance
- Computer System Validation
- Computer Software Assurance
- Program and Project Management
- Vendor and Financial Management
- Executive Stakeholder Management
- Risk and Dependency Management
- Organizational Change Management
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
- PMP
- PgMP
- SAFe Agilist or SAFe Program Consultant
- ITIL Foundation
- Certified Quality Auditor
- Certified Quality Engineer
- ASQ or RAC certification
- Lean Six Sigma Green Belt or Black Belt
- Agile or Scrum certification
- Program Management
- Quality Systems
- Compliance Systems
- eQMS
- Digital Quality
- CAPA
- Deviations
- Change Control
- Document Management
- Audit Management
- Training Management
- Complaints Management
- Supplier Quality
- Regulatory Compliance
- 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 Management
- Change Management
- Digital Transformation
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 (http://us.nttdata.com/en/compliance#eeos) . If you'd like more information on your EEO rights under the law, please click here (http://us.nttdata.com/en/compliance#know-your-rights) . For Pay Transparency information, please click here (http://us.nttdata.com/en/compliance#ppnp) .
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