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.
