Digital Transformation Program Manager

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.

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