Deviations QMS Digital Transformation Lead

Jobtailor; New Jersey; On-site; USD 150,000 - 200,000; Full time

Job summary

Jobtailor seeks a senior professional to lead the digitization of Deviations QMS processes within a regulated pharma environment. You will drive implementation of Deviations and Issue Management in Veeva Vault QMS, migrate data from legacy systems, and ensure SAP S/4HANA integration.

You will define the product vision and roadmaps for Deviations capabilities, translate business strategy into IT initiatives, and own requirements and GxP documentation while guiding cross-functional teams in global

Qualifications

• 10+ years in pharma industry with listed skills
• Experience leading large, cross-divisional process improvements
• Experience with cloud platform rollouts in regulated environments
• Backlog definition with development teams
• Leadership in matrix organizations
• Hands-on QMS knowledge: Veeva Vault QMS, Trackwise, SAP, Appian
• Experience with Deviations AI/ML/Gen AI solutions
• Strong SDLC, validation/testing, and regulatory compliance knowledge
• Excellent communication, analytical, and change-management skills
• Willingness to travel ~10% and work in GMP contexts

Responsibilities

• Lead digitization of Deviations QMS processes within QMS.
• Lead implementation of Deviations and Issue Management into Veeva Vault QMS.
• Migrate processes/data to Veeva Vault QMS with SAP S/4HANA integration.
• Define product vision, roadmaps, and value maps for Deviations capabilities.
• Translate strategy into prioritized IT/product initiatives with SMEs.
• Own requirements, translation to dev, and GxP system docs.
• Drive end-to-end delivery of large global cloud deployments.
• Lead cross-functional teams and mentor junior members.
• Ensure SDLC/GxP-compliant design, testing, and operation.
• Govern global design for Deviations solutions; align investments.
• Monitor metrics, optimize total cost of ownership.
• Lead AI/ML design/delivery for Deviations processes.
• Liaise with partners, vendors, and stakeholders; advocate user-centered design.
• Influence stakeholders, manage priorities, and enable new ways of working

Skills

Product backlog prioritization

SDLC practices

GxP compliance

Regulatory compliance

Change management

Stakeholder management

Team leadership

Analytical problem solving

Exceptional communication

Deviations Management

Issue Management

AI/ML solutions

Data migration

Cross-functional leadership

Education

Bachelor's degree in computer science, engineering, biology, chemistry, or a related scientific/technical field

Advanced degree (MS or MBA) in a scientific, engineering, or technical discipline

Tools

Veeva Vault QMS

Trackwise

SAP

Appian

UiPath Solutions

SAP S/4HANA

AI/ML Technologies

Job description

Jobtailor seeks a senior professional to lead the digitization of Deviations QMS processes within a regulated pharma environment. You will drive implementation of Deviations and Issue Management in Veeva Vault QMS, migrate data from legacy systems, and ensure SAP S/4HANA integration.

You will define the product vision and roadmaps for Deviations capabilities, translate business strategy into IT initiatives, and own requirements and GxP documentation while guiding cross-functional teams in global