Julia Panciera Ms, Mph Email & Phone Number

Boston, Massachusetts, United States

- Management of vendor certificates and declarations in support of GMP/GDP activities- Assist in the facilitation of GMP Quality Leadership Team (QLT) including maintaining QLT documentation andaction items.- Support the maintenance of inspection related documentation and inspection readiness plans associated withregulatory findings.- Continued support of the Product Complaint process including triage, complaint investigations complaint approvals, participation in cross-functional triage and Quality Management Review meetings.

Boston, Ma

- Manage the processing and authoring of clinical and commercial product complaints, including intake, initial evaluation and triage, coordinating with CMOs for external investigations, organize product complaint sample returns and complete sample evaluation, perform Root Cause Analysis, identify Corrective Actions and Preventative Actions.- Conduct cross-functional triage meetings to foster cross-department collaboration- Perform and author monthly reconciliation reports with various reporting sources- Participate in quarterly Quality Management Review (QMR) meetings for Product Complaints and review of Quarterly Trend Reports- Organize training to cross-functional teams on the Product Complaint process

Boston, Ma

- Communicate between the families enrolled in the Vertex Guidance and Patient Support (GPS) program, their care team, health plan, and specialty pharmacies to ensure rapid treatment access and to provide ongoing adherence support.- Organize and manage quality-based projects through the GPS Compliance Rep Team in order to streamline GPS processes, such as Compliance Event Reporting, Adverse Event (AE)/ Product Complaint (PC) Reporting, and Work Instruction updates.- Completed 6 month Quality Assurance rotation in CMC Patient Safety QA. Responsible for entering and investigating Product Complaints.- Implement and troubleshoot various Customer Relationship Management (CRM) systems, including Salesforce Lightning, Mosaic, and New Voice Media. - Managed AE/PC reconciliation with Global Patient Safety and CMC Patient Safety QA and led team-wide AE/PC trainings to ensure consistent documentation and reporting.- Assisted in developing and executing corrections following recommendations from a GPS pharmacovigilance audit.

Cambridge, Ma

- Worked with the Director of Performance Improvement to identify root causes for decreased patient retention, and performed market assessment to identify growth-opportunity recommendations.- Developed sustainable strategies for improvement with regards to decreased patient volume for colonoscopy services.

Master Of Public Health (Mph), Health Policy And Management

Master Of Science (M.S.), Medical Science

Bachelor’S Degree, Biology

Activities and Societies: Running Club, Special Olympics Volunteer, WDOM Radio Show Co-Host