Sr. Computer Systems Validation (CSV) Lead/ Consultant Resume

SUMMARY

Twelve plus (12+) years of management experience
Sixteen plus (16+) years of managing projects in a Pharmaceutical/ Biological/ Medical Device environment
Strong knowledge of change management, quality systems, and software/computer validation
Excellent communications, organizational and troubleshooting/ problem - solving skills
Valuable interpersonal skills: quickly build and maintain good rapport with client/customer
Team player, self-motivator, ability to work with little or no supervision
Comfortable in a fast-paced, constantly changing environment

PROFESSIONAL EXPERIENCE

Sr. Computer Systems Validation (CSV) Lead/ Consultant

Confidential

Responsibilities:

Support all CSV activities at multiple sites and ensure procedural consistency
Manage tasks, schedules, and deliverables associated with the overall initiatives related to Laboratory, Manufacturing, Engineering, and Enterprise Systems
Create, review, and/ or approve all CSV Validation Plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Requirements Traceability Matrix (RTM), Validation Reports, SOPs, Change Control Documentation, Risk Assessments, and Validation Summary Reports
Build and maintain trusting, collaborative relationships and partnerships with internal stakeholders to ensure key business objectives are satisfied

Confidential

Sr. Consultant

Responsibilities:

Support and oversee all CSV activities at multiple sites (Durham, NC, Boulder, CO, Houston, TX, and Leuven, Belgium) and ensure procedural consistency
Manage cost, tasks, schedules, and resources associated with the overall initiatives related to Laboratory, Manufacturing, Engineering, and Enterprise CSV and Lab Support efforts
Review and approve all CSV Validation Plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Requirements Traceability Matrix (RTM), Validation Reports, SOPs, Change Control Documentation, Risk Assessments, Periodic Compliance Reviews and Validation Summary Reports
Ensure a high degree of Inspection Readiness for Systems/Infrastructure and support internal and external customer and regulatory audits
Build and maintain trusting, collaborative relationships and partnerships with internal stakeholders to ensure key business objectives are satisfied
Initiate and manage all data integrity and Part 11 compliance gap assessments and remediation projects for approximately 60+ existing systems

Confidential

Sr. IT Validation/ Project Lead

Responsibilities:

Manage change requests related to the GLIMS system; determine validation approach, and work with the business to ensure accuracy and timeliness
Track and report on project milestones/ deliverable to the System Owner and Management
Manage validation efforts for multiple Divestiture Projects (Vaccine Division was sold to GSK and CSL)
Facilitate project meetings and communicate daily with the project teams in Germany, Italy, and Liverpool

Confidential

QC LIMS Sr. Project Manager

Responsibilities:

Managed cost, tasks, schedules, and resources associated with the overall initiatives related to the LIMS Project
Proposed and implemented a QC LIMS support model to include a Change Management Process
Managed the LIMS Support Team; assigned resources, tracked progress, and reported status
Provided guidance/ support to QC to understand the business needs and work with IT to define the best approach
Attended/ facilitated project and stake holder meetings

Confidential

Sr. IT Validation Lead

Responsibilities:

Project Lead tasked with determining overall validation approach for QC e-Lab Project
Authored validation documentation as needed
Tracked and reported on project milestones/ deliverable to the System Owner and Management
Project Lead tasked with determining overall validation approach for IT/ QC systems
Provided guidance/ support to IT employees with regards to Computerized System Validation requirements
Created and maintained change controls and validation deliverables for IT and QC systems
Coordinated documentation, testing, and change management activities
Member of the IT Change Control board; provided quality assurance oversight for all IT Infrastructure projects