Digital Transformation Program Manager

Nitto Avecia; Milford (MA); On-site; USD 152,600 - 186,700; Full time

Job summary

Nitto Avecia located in Milford, Massachusetts is seeking a Digital Transformation Program Manager responsible for overseeing Quality digital projects, including eQMS and LIMS implementation. You will collaborate with cross-functional teams to ensure projects meet compliance and GxP standards.

The ideal candidate has over 5 years of project management experience in regulated industries and a Bachelor's degree in a relevant field. The role emphasizes strong leadership and communication skills.

The annual salary range is between $152,600 and $186,700.

Qualifications

• 5+ years of experience as a Project or Program Manager in regulated industries.
• Demonstrated experience managing system implementation or upgrade projects.
• Strong understanding of GxP environments and cross-functional Quality processes.

Responsibilities

• Manage end-to-end delivery of Quality digital projects.
• Develop project charters, schedules, milestones, and communication plans.
• Facilitate project meetings and ensure team alignment.

Skills

Project management in regulated industries

Understanding of GxP environments

Proficiency with PM tools

Exposure to AI and machine learning

Education

Bachelor’s degree in Engineering, Life Sciences, IT, or related field

Tools

MS Project

Jira

Smartsheet

Job description

About This Opportunity

The Digital Transformation Program Manager is responsible for planning, coordinating, and executing cross-functional projects supporting electronic quality management system (eQMS), Laboratory Information Management System (LIMS), Electronic Batch Records (eBR), and AI-enabled Quality initiatives. This role ensures projects are delivered on time, within scope, and in compliance with GxP and data integrity requirements. The Program Manager works closely with Quality, IT, Manufacturing, QC, Validation, Regulatory, and Data teams to translate business needs into structured, executable project plans.

Key Responsibilities

• Manage end-to-end delivery of Quality digital projects, including eQMS, LIMS, eBR, and AI use cases


• Develop project charters, schedules, milestones, RAID logs, and communication plans


• Track scope, timelines, risks, and dependencies across multiple workstreams


• Ensure clear handoffs between design, build, validation, deployment, and sustainment phases


• Act on behalf of project owners to enforce agreed timelines, track commitments, and drive cross‑functional teams toward timely completion and formal project closure


• Facilitate project meetings and working sessions across QA, QC, Manufacturing, Process Development, Analytical Development, Engineering, QA-Validation, IT, and vendors


• Drive alignment on requirements, priorities, and deliverables


• Escalate risks and issues in a timely, structured manner


• Support change management and user adoption activities


• Coordinate project activities to ensure compliance with data integrity and CSV expectations


• Support validation planning, documentation readiness, and change control execution


• Maintain inspection‑ready project documentation


• Support implementation of AI‑enabled initiatives (e.g., batch record review, deviation triage, enhanced PowerBi reporting)


• Coordinate activities between cross‑functional teams


• Track risks related to AI use in regulated environments and ensure appropriate governance steps are followed


• Provide periodic summaries to Quality and Digital leadership on relevant AI advancements, case studies, and potential applications applicable to Avecia operations


• Identify opportunities where emerging AI capabilities could improve efficiency, compliance, data integrity, or inspection readiness


• Prepare routine project status updates for Quality leadership


• Maintain dashboards and metrics on project health


• Ensure transparency on progress, risks, and decision points

Required Skills/Abilities

• Bachelor’s degree in Engineering, Life Sciences, IT, or related field


• 5+ years of experience as a Project or Program Manager in regulated industries (pharma, biotech, medical device)


• Demonstrated experience managing system implementation or upgrade projects (eQMS, LIMS, MES/eBR, or similar)


• Strong understanding of GxP environments and cross‑functional Quality processes


• Proficiency with standard PM tools (MS Project, Smartsheet, Jira, or similar)


• Exposure to AI, Power BI, machine learning, or large language model projects


• Familiarity with AI governance, validation considerations, and risk assessments


• Experience working with vendors such as Veeva, TrackWise, Biovia, or Siemens


• PMP or equivalent project management certification

The annualized salary for this role is between $152,600.00-$186,700.00.