Victoria Gadbois

• Responsible for ensuring products and processes meet established quality standards and compliance requirements.
• Conduct quality review of manufacturing batch records and collaborate with production teams to resolve errors promptly.
• Manage and track deviation, CAPA, and Change Control records, ensuring adherence to standard timelines and timely resolution.
• Lead Risk Assessments, Cause Mapping, and Root Cause Analysis to determine deviation causes and prevent recurrence.
• Act as a single point of contact for client interface meetings, representing all Quality activities and ensuring client expectations are met.
• Support batch disposition processes to ensure timely deliverables to clients and participate in Daily Tier meetings to update leadership on deviation statuses.
• Work independently and as part of a team, adapting to changing priorities and managing multiple assignments while meeting deadlines.
• Exhibit expertise in GMP compliance and FDA regulations, with a commitment to quality and continuous improvement.

This section denotes an extended step away from the paid workforce to significantly contribute to my family.

• Scheduled and maintained all project deliverables within our Jira Kanban boards, project status reports, and the overall project plan (MSP).
• Planned and managed activities supporting RFI/ RFP submission.
• Coordinated vendor assessment efforts and drove business ERP selection process.
• Facilitated team meetings, assignment planning, target completion dates and more.
• Managed coordination of deliverables and tracking for all cross-functional team members (Engineering, Design Architects, Data Science, BA and PM).
• Prepared and delivered executive level presentations.
• Creation of training and program on boarding documents.
• Requirements gathering and Process Mapping for current / future state.

• Managed all operational tasks necessary to advanced clinical programs through multiple phases of study/ commercial launch; managed stage gate handoffs between functional areas to achieve key program milestones, ultimately leading to timely FDA submissions and product launches.
• Identified potential project risks with the team and proactively developed mitigation strategies to present to senior leadership, communicated progress against chosen strategy to all stakeholders.
• Fostered excellent communication streams and working relationships with department leaders, line managers and individual contributors within functional groups.
• Proactively coordinated cross functional activities, meetings and manufacturing drive program progression.
• Effectively created and maintained presentations, dashboards, project files and timelines for reporting up-to-date information to team and management.
• Designed process flow diagrams and guidance documents to serve as work instructions for new business processes and improvements.
• Implemented new constructive training concept summaries, case studies, and playbooks to foster a “uniform department” via training initiatives.
• Lead knowledge management efforts through Lessons learned processes focused on highlighting business ‘lessons learned’ to reduce errors and implement preventive solutions.

• Produced monthly reports using advanced Excel spreadsheet functions.
• Identified, analyzed and interpreted trends or patterns in complex data sets.
• Created various Excel documents to assist with pulling metrics data and presenting information to stakeholders for concise explanations of best placement for needed resources.
• Prepared Certificate of Analysis’ and Summary of Analysis’ for all lot release material.
• Worked closely with mfg., quality assurance, regulatory affairs, and supply chain to ensure batch was on schedule for arrival and testing completion to meet lot release for business need.
• Utilized data visualization tools to effectively communicate business insights.
• Implemented document control efforts for all QC test data by uploading files to a digital database. Managing hard copy files (filing, scanning, archiving).