Gabe Vega Email & Phone Number

Seattle, Washington

▪ Project Lead for migration of Quality Systems from Celgene & Juno systems to Bristol Myers Squibb (BMS) system including Document Management and Deviations/CAPA.▪ Project Lead for migration for Inspection Systems from AuditUtopia to ACE. ▪ Establishing Quality KPI metrics and processes for all Cell Therapy sites.▪ Assisting in establishing a harmonized monthly Quality Council presentation across all sites.▪ Performed interim Document Control responsibilities.▪ Established template and wrote Product Quality Complaint Trend report for Cell Therapy for both Commercial and Clinical complaints.▪ Mentoring individuals on Developmental operations versus Commercial operations from a compliance perspective.▪ Providing guidance on proper regulatory commitment fulfillment.▪ Providing communications for all Cell Therapy individuals that are impacted by the specific integration projects▪ Experience with Veeva and eQRMS Quality Systems as well as ComplianceWire Learning Management System.▪ Mentor individuals on the Deviation process.Assist in integration activities and decommissioning of products.▪ Provide support where needed to support the Compliance and Quality team.

Broomfield, Co

Responsible for maintaining compliance with Quality Systems procedures and when necessary driving process improvement projects Develops and provides training to users of the Quality Systems (TW, eSDMS) Oversight of Site Quality Metrics Generates and reports site quality metrics on a weekly, monthly and quarterly basis Assists with creation of metric presentation slides for site leadership forums in-cluding Site Quality Council, North America Dashboards, Quality Systems Review, etc. Compiles site metrics for reporting of Global Cockpit metrics Leads improvement projects as assigned for enhancement of Quality Systems across the site Supports Regulatory Inspections and internal/customer audits as Quality System subject matter expert. Interfaces with management to assure Quality Systems meet business needs while maintaining compliance. Documentation System: Manages the SOP periodic review process and provides periodic reporting to ensure compliance to procedure, cGMP requirements and established metrics. Manages electronic Document Management system(s) and their interface with other systems and their owners throughout the facility to maintain a regulatory compliant state. Change Control System: Acts as lead site change control coordinator and provides guidance and support to all cross-functional departments who utilize centralized change control Performs reviews of change control proposals/requests and provides feedback and mentoring to Requestors Chairs and facilitates all change control Technical review and Board review meetings Verifies completion of required change control tasks prior to change im-plementation and closure of change control records Investigation System: Generates trend reports and works with site to address trends as identified APR: Generates APR reports for upper management review and approval. Interacts with upper management regarding APR reports and may attend APR meetings with upper management.

QA support of solid dose pharmaceutical manufacturing and packaging including:QA floor support providing path-forward decisions for quality events Internal audits of facilities, warehouse and GMP systems AQL sampling for in process defect evaluation as well as validation Training for packaging line clearances, Zone 2 gowning, and New Employee OrientationMinor Quality Incident event assessmentCorrective and Preventative Action implementation and effectiveness assessment Participation on process improvement teams

Responsible for ensuring site-wide compliance to all applicable state/federal regulations affecting work performed at site and primary back-up for QA ManagerMaintained Drug licensure and renewals for 48 statesParticipated in and prepared for customer and regulatory audits Ensured warehouse operations complied with cGMP, DEA and USP requirements for room temperature and cold storagePrepared and executed validation protocols for temperature mapping of warehouses as well as validation of computerized systems per GAMP5 in order to comply with 21 CFR part 11Advised and trained field and internal personnel on issues relative to company policies, as well as state and federal regulations (i.e. Fraud and Abuse laws, HIPAA, OIG, cGMP, DEA, PDMA and PhRMA code).Served as primary QA resource to Department Managers for problem identification, reporting, resolution, and monitored improvement plansPerformed Quarterly internal audits of processes, policies and programsGenerated Standard Operating Procedures, Work Instructions and validation protocol documents

Investigated Error Report shortages in warehouse and production Performed daily Inventory Count Request Collaborated with Material Program Managers and production floor to fix Bill of Material issuesImplemented shipping error report to reduce backlog of material showing in ship locationStarsys Research

Verified MIL Specs/certifications on all incoming stock (Fabricated, Electronic, Purchased)Accurately accounted for all hardware from the time it was received until issue to ManufacturingGenerated all fabrication orders for processing and tracking space flight fabricated components Performed Quarterly physical inventoriesMaintained a 99% physical inventory accuracy with a total value over $100,000Pulled and issued parts to Manufacturing Orders