Project Program Mgmt. Specialist Advisor
Hace 10 horas
Puerto Vallarta, México
NTT DATA, Inc.
Jornada completa
EUR 450,000 - EUR 850,000 Por obra
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Date: Aug 13, 2026
Location:
GDL, JAL, MX Company: NTT DATA Services NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. We are currently seeking a Project Program Mgmt. Specialist Advisor to join our team in GDL, Jalisco (MX-JAL), Mexico (MX). Project Overview 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.
Key Responsibilities
Program Leadership
- 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. Quality & Compliance Systems Delivery
- 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. Program Planning & Execution
- 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. Compliance & Validation
- 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. Business & Stakeholder Management
- 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. Risk, Issue & Dependency Management
- 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. Financial & Vendor Management
- Manage program budgets, forecasts, purchase orders, contracts, and financial performance.
- Oversee software vendors, system integrators, consulting partners, and managed service providers.
- Monitor vendor
Location:
GDL, JAL, MX Company: NTT DATA Services NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. We are currently seeking a Project Program Mgmt. Specialist Advisor to join our team in GDL, Jalisco (MX-JAL), Mexico (MX). Project Overview 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.
Key Responsibilities
Program Leadership
- 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. Quality & Compliance Systems Delivery
- 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. Program Planning & Execution
- 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. Compliance & Validation
- 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. Business & Stakeholder Management
- 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. Risk, Issue & Dependency Management
- 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. Financial & Vendor Management
- Manage program budgets, forecasts, purchase orders, contracts, and financial performance.
- Oversee software vendors, system integrators, consulting partners, and managed service providers.
- Monitor vendor