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 internally across all department and with 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:
- Bachelors 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 range for this role is $152600.00 - $186700.00.
Required Experience:
Manager
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 Qu...
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 internally across all department and with 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:
- Bachelors 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 range for this role is $152600.00 - $186700.00.
Required Experience:
Manager
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