Digital Transformation Program Manager

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

Job summary

Avecia Pharma is seeking a Digital Transformation Program Manager to plan, coordinate, and execute cross-functional projects across eQMS, LIMS, eBR, and AI-enabled quality initiatives. You will ensure on-time delivery within scope and GxP compliance, partnering with Quality, IT, Manufacturing, QA, and Data teams to translate business needs into executable plans.

The role requires 5+ years in regulated industries, strong PM tool proficiency, and experience with AI governance and vendor

Qualifications

• Candidate must have a track record of delivering complex digital projects in regulated environments.
• Experience managing system implementation or upgrade projects (eQMS/LIMS/MES/eBR) in pharma/biotech settings.
• Strong understanding of GxP and data integrity requirements.
• Proficiency with PM tools (MS Project, Smartsheet, Jira) and analytics tools (Power BI).
• Familiarity with AI governance, validation considerations, and risk assessments.
• Experience working with vendors (Veeva, TrackWise, Biovia, Siemens).
• PMP or equivalent certification.

Responsibilities

• Manage end-to-end delivery of Quality digital projects (eQMS, LIMS, eBR, 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
• Enforce timelines, track commitments, and drive cross-functional teams to closure
• Facilitate project meetings across QA, IT, Manufacturing, 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 activities for data integrity and CSV compliance
• Support validation planning, documentation readiness, and change control
• Support AI-enabled initiatives (batch record review, deviation triage, Power BI reporting)
• Coordinate cross-functional activities and governance steps for AI use
• Provide status summaries to Quality and Digital leadership on AI advances
• Identify opportunities where AI can improve efficiency and inspection readiness
• Prepare routine project status updates for Quality leadership
• Maintain dashboards and metrics on project health
• Ensure transparency on progress, risks, and decisions

Skills

Project management

Regulated industries

Cross-functional collaboration

GxP environments

AI governance familiarity

Vendor management

Stakeholder communication

Education

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

Tools

MS Project

Smartsheet

Jira

Power BI

Job description

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
• 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.