Strategic and operational leadership for the QMS workstream within a complex, enterprise-level laboratory transformation program, focusing on architecting and deploying a modernized, digitized Quality Management System.
Compensation
$173,200 - $272,600
Responsibilities
Define, lead, and execute the QMS integration strategy for the lab transformation initiative.
Oversee harmonization and evolution of quality processes including deviation management, investigations, CAPA, change control, risk management (ICH Q9), and computerized systems validation (CSV/CSA).
Oversee the eQMS and review/understand underlying code to ensure compliance.
Partner with IT/Digital Quality and Automation engineers to embed Data Integrity by Design (ALCOA+) and Computer Software Assurance (CSA) principles.
Ensure all modernized QMS processes, policies, and SOPs comply with global cGMP regulations (FDA 21 CFR Part 11/210/211, EU Annex 11, ICH Q9/Q10, WHO).
Lead GxP validation strategy and execution for NetSuite and related systems, ensuring compliance with 21 CFR Part 11 and other regulatory requirements.
Locations (2)
Plano, Texas, United States
Chicago, Illinois, United States
Compensation
NTT DATA provides a reasonable range of compensation for U.S.-based positions. The starting pay range for this remote role is [$80.57 to $90.51]. This range reflects the minimum and maximum target compensation for the position across all US locations.
Responsibilities
Develop and maintain validation strategy for NetSuite and associated applications
Define GxP impact, intended use, validation scope, and approach
Facilitate or lead Computer Software Risk Assessments
Apply risk-based approach to validation rigor and testing
Establish validation boundaries between systems
Requirements
Bachelor's degree in life sciences, engineering, quality, information technology, computer science, or a related discipline
Lead end-to-end MES program delivery across IOPS sites, managing cross-functional teams, system integrators, and vendors to deliver compliant manufacturing execution system capabilities.
Compensation
Salary Range (annually) $108,000.00 - $206,100.00
Responsibilities
Own end-to-end MES program delivery across IOPS sites
Lead and direct cross-functional delivery teams
Partner with business owners and senior stakeholders to define MES program scope, roadmap, deliverables, and timelines
Proactively identify, triage, and remove impediments
Ensure all MES deliverables meet GxP, ALCOA+, and 21 CFR Part 11 requirements
Requirements
BS/BA in Information Technology or a related field
Nice to have: Experience delivering MES programs including electronic batch records, recipe management, and integrations with automation/SCADA, ERP, LIMS, and historian systems
Nice to have: Agile Scrum Master certification (CSM or PSM)
Director– Quality Management Systems (QMS) & Digital Quality GovernanceMerck · Wilmington, US