It Senior Manager - Bss Quality Regulatory And Engineering Solutions
Current• Overall responsibility for RUN Support Services for all 100+ Quality Regulatory and Engineering Solutions (QRES) IT systems.o Oversee the 2 QRES Client Services Managers FTEs (each owns 50+ systems).o Oversee the work of the 3rd Party Managed Service Providers (IBM and Cognizant).o Ensures systems (mostly quality critical) are running as efficiently as possible and maintains business continuity 24/7.o Monitor support trends and identify areas to improve overall support.o Ensure system compliance (processes and policy requirements).o Support in the internal and external audits and pre-audits.o Escalation for any major outages (P1 or P2 issues).o Support RCAs (Root Cause Analysis) and CAPAs (Corrective Action Preventative Actions).o Support Tech-Debt reductions.o Support and/or drive Security Vulnerability improvements.o Track/monitor/support system licenses and license requirements.• Overall responsibility for Plan / Build and RUN Support for the MED DEV EPIQ System (and related systems).o EPIQ includes the following quality management functions for Abbott Medical Device (MED DEV) Division (Complaint Handling, CAPA, Audit, Nonconforming Materials, Supplier Quality and Microbiology).o EPIQ is a quality critical application that has more than 3,000 Active Users (4,000+ Mobile).o Manage 12+ members of the EPIQ IT Delivery Team (PMs, BSAs, Architect, Developers, Testers, etc)o Annually team delivers 5-10 medium to large scale IT projects for MED DEV ($250K to $2Million).o Oversee the RUN Support Team (3 members) that ensures business continuity of the system and supports account access via EPIQ Access Control application (EAC).o Provide ongoing coaching and mentoring for the entire team (especially the 4 FTEs).o Work closely with the MED DEV Business Relationship Manager (BRM), BRM Director, and product vendor (EtQ) leadership to define and maintain the EPIQ 3–5-year roadmap.