Validation Lead - SaaS GxP Resume Cambridge, MA - Hire IT People

SUMMARY:

Having worked in capacity of Validation Lead, IT Project Manager, SQA Leader and Business Analyst for the past 17 years, with continued success in meeting targeted objectives, I am confident that I can make a valuable contribution to your organization.

COMPETENCIES:

Technical and GxP Project Management
Agile and Waterfall SDLC Methodologies
Validation SDLC GxP SaaS and Infrastructure
FDA, ISO13485, CE Mark, 21CFR11, 510K
IEC 60601, 62304 Software Support
Medical Device Launch Software V&V
Hands Functional Systems Testing
Quality Management Systems Development
ISO 14971: 2012, 93/42/EEC (2007/47/EC)
Software Quality Assurance Management

TECHNICAL ENVIRONMENTS:

SQL, Sybase, UNIX, Toad Clear Quest, DOORs, Dreamweaver, Eclipse, Oracle 11x, E-Test, Flash FF, HTML, Java, JavaScript, Jenkins and Squish Automation tools, JIRA, Life-ray, CENER, Lotus Notes, Mac OS, Magic, Mantis Tracker, Microsoft .NET, MS Access, MS Office, MS Project, MS-DOS, Mobile OS, Outlook, Paradox, Python, QTP, SAP, SharePoint, Web Ex, Visio, .Net, ASP.Net, C#.Net, VB 6.0 & ASP, Windows Embedded (CE, CE 6.0).

PROFESSIONAL EXPERIENCE:

Confidential, Cambridge, MA

Validation Lead - SaaS GxP

Responsibilities:

Created Validation Plan, Testing Plan, Test Report, Validation Summary Report for large GxP projects.
For Infrastructure projects additionally created the Project Plan and drove Project deliverables for the group.
Provided overall SDLC guidance and support, Reviewed requirements and functional solutions
Defined SDLC/validation strategy, led the relevant SDLC activities as defined in the Validation and Project.
Ensured SDLC deliverables are accurate and appropriately approved.
Ensured the validation and testing activities are appropriately delivered.
Identified Post Project Retrospective Lessons learned and suggested improvements to SOPs and Processes.

Confidential, Danver, MA

System V&V Leader

Responsibilities:

Completed a comprehensive gap analysis for all SOPs related to SQA and DEV groups.
Identified Risks and gaps within Specifications, Test Cases and Process for SQA and interdepartmental relationships.
Conducted internal Audits of Engineering and Regulatory department.
Enhanced Bug tracking process by creating standardized Work Instructions.
SQA Team Management, with 3 direct reports: Assisted with transition from DEV to R&Q organizational structure.
Lead the staff to create a cohesive team, with a morale building mindset.

Confidential, Lexington, MA

Director of Development

Responsibilities:

Created over 50 test protocols for V&V system testing and performed System and Software Validation.
Organized and facilitated user requirements and functional requirements creation and updates.
Tested all releases of the Confidential software to align with customization requirements.

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Validation Lead - Saas Gxp Resume

Cambridge, MA

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