Select how often (in days) to receive an alert: Create Alert
Date:
Aug 13, ****
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 integral 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 *****
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 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.
Change Management & Adoption
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.
Required Qualifications
Bachelor's degree in Life Sciences, Quality Management, Information Technology, Engineering, Computer Science, or a related discipline.
*****+ 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.
Required Technical & Functional Expertise
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
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
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
Key Skills
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 *****
ALCOA+
CSV
CSA
Executive Stakeholder Management
Vendor Management
Budget Management
Risk Management
Change Management
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, .
NTT DATA endeavors to make 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 .
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 .
#J-*****-Ljbffr

📌 Project Program Mgmt. Specialist Advisor (Jalisco)
🏢 Ntt Data
📍 Jalisco