- Seasoned, client - facing IT Professional with over 18+ years in experience; specializing in Project Management (10+ years), Business/Systems Analysis (10+years), SDLC (Waterfall and Agile), Validation and Quality (15+years).
- Expertise in Process, providing guidance for regulated environments such as Biotech, Pharmaceutical, Medical Device and Financial industries.
- Well versed in Confidential and Confidential Regulations especially as they relate to Computerized Systems and Clinical Data.
- Experienced in working effectively with non-IT (Scientific, Clinical, Financial, Business/Customer groups, Senior Management) and IT personnel alike.
MANAGER, SOFTWARE QUALITY ASSURANCE
- Manage the SQA Team and own the Software Quality Process
- Work closely with Software team to define testing methodology
- Extensive Project Management and Change Management
- Owner and Administrator of Requirements Management System (JAMA) for the whole company
- Owner of Defect Review Board and Defect Tracking Processes for the company
- Facilitate the planning and execution of quality management plans
- Develop strategies to improve software quality operations and provide guidance to other engineering groups on testing processes
- Conduct resource management, forecasting and work assignments. Develop the QA team
- Tracks metrics on appropriate scorecard- test metrics, quality metrics, etc.
- Perform JQL (Jira Query Language) and SQL queries to extract data
- Provide metrics, status updates and presentations for VPs and senior management
- Vendor management, including but not limited to, working directly with vendors for test resources/personnel and vendors providing engineering tools (Requirements Management Tools, Defect Tracking tools, etc.)
- Researching additional or alternative tools for Engineering and Quality processes
- Own complaint process for SW complaints - thoroughly investigate and close out complaints from the field.
Technologies/Skills Used: Jira, JAMA, Confluence, SQL, MS Project and Visio, Advanced Excel (charts, pivot tables), Quality/Validation, Business/Systems Analysis, Workflow Mapping, Process Mapping, DRB Chair, Data Management, Vendor Management, Project Management, Change Management
- Worked directly with client to manage implementation of website and software for a Data Analytics company.
- Worked with CEO to develop an efficient Product roadmap that has led to a smooth workflow process for the development team.
- Created Business Cases based on Project Charter and customer requirements. Managed stakeholders and their requirements. Translated Business Requirements into System Requirements for the Development & Testing teams.
- Negotiated and managed requirements with the external vendors. Managed Development and Testing.
- Created and delivered Project management plan for four different divisions, technology development, business process development, external vendor communications management, and funding process.
- Helped management to develop a high performance advisory board on product deliverables.
Technologies/Skills Used: MS Project, Visio, SharePoint, WordPress, PowerPoint, MS Office, Quality/Validation, Business/Systems Analysis, JAD sessions Use Case Models, Data Management, Vendor Management
Confidential, Santa Clara, CA
SENIOR PROJECT MANAGER-IT
- Core Team Member and acting as Project Lead and Business/Customer Representative
- Managing End to End deployment of a system or solution to support latest industry innovation. From creating business cases to leading Requirements review/gathering for creation of BRD to UAT design to system launch & deployment and post-support. Creating ‘As-Is’ and ‘To-Be’ process flows. Managing all business-related processes including budget, resource and stakeholder management.
- Commanding management of multiple projects, in addition to acting as a consultant to business units and other vested parties. Demonstrated proficiency in all areas of clinical project management and very knowledgeable of the Clinical Trial and overall Drug Development process.
- Lead risk management activities by working with team to identify risks to systems/solution implementation and outcomes, present findings to management, and implement basic mitigation.
- Act as point person in working with outside vendors and research partners such (EDC vendors, IVRS/clinical core labs in contract development and negotiation) as well as point person for executive level employees.
- Excellent knowledge of CFR, GCP, local regulations and internal procedures required for clinical trials;
- Set quality and compliance goals for the project and monitor/manage compliance as part of clinical project management; Ensuring compliance with applicable corporate and divisional policies and procedures.
- Auditing of IT/Technical and Business Systems Documents (COTS, Technical Requirements, Software Verfication Report-SVR, etc.)
- Prepare and update project budget using MS Project; Monitor spending against specific parts of project budget.
- Create for new clinical system implementation.
- Worked as Lead PM on Risk Master List & Clinical Evaluation Report (CER) projects and PM on Wearable Technologies
Technologies/Skills Used: MS Project, Visio, SharePoint, PowerPoint, Salesforce, Documentum, MS Office, Confidential /GcP, Quality/Validation, Business/Systems Analysis, Use Case Models, Vendor Management
Confidential, South San Francisco, CA
SYSTEMS/IT PROJECT MANAGER
- Leading study-level system requirements meetings to ensure system requirements are accurately documented to support system design by the vendor
- Liaison between internal clinical trials teams and vendors to create/strategize and implement best solutions of IxRS products
- Driving processes to implement clinical systems (IxRS, ePro/eCOA, EDC and CTMS products).
- Performing Vendor RFP Reviews & Negotiation, Supplier Sourcing
- Vendor Management, Conflict Management and Solution oriented
- Providing Systems to both End Users and to Vendors
- Creating, Managing & Driving UAT Process for System Implementations and upgrades
- Utilizing Visio, MS Project and Microsoft SharePoint/TouchPoint and Google Platforms.
- Knowledgeable in Good Clinical Practices, and Confidential regulations and ensuring Confidential validated solutions comply with Confidential regulations throughout the solution lifecycle. Very knowledgeable of Clinical Trial process and overall Drug Development process.
Technologies/Skills used: SharePoint/TouchPoint, MS Project, Google Platforms, Visio, PowerPoint, MS Office, IxRS, EDC, CTMS, eCRF, Vendor Management, UAT, Confidential /GcP/GmP, Data Mapping
Confidential, San Francisco, CA
TECHNICAL PROJECT MANAGER
- Create high level technical presentations for Executives & Senior Management
- Document & Improve QA Process
- Develop in-depth knowledge of systems and technology and document them
- Create in depth defect metrics (utilizing HPQC and Clearquest) and KPIs
Technologies/Skills Used: HPQC, PowerPoint, PMM, Clearquest
Confidential, San Francisco, CA
- Manage the development of new IRT/IxRS/IvRS SaaS systems for new clients, while maintaining current software implementations for existing clients.
- Establish baseline Requirements and Manage Change Control (including SOW) throughout the development process.
- Business Systems Analysis -Translate Clinical Trial Study Protocols into System Requirements.
- Build effective partnerships with other internal teams to move project through all phases of the development process utilizing SharePoint and MS Project-like tool.
- Develop and maintain Project Schedule, identify and track milestones and Identify and Manage Cross-Functional dependencies, perform Risk Impact Assessments, Troubleshoot & Research, Root-Cause Analysis, and use of SQL queries.
- Manage ongoing reporting of project health and profitability to internal and external stakeholders. Risk Management and Risk Mitigation.
- Manage/Conduct Kick Off Meetings (KOM), Project Launches, Formal UAT, End-User, System Decommissioning
- Act as primary point of contact for clients, keeping them apprised of all project developments while maintaining stellar client satisfaction.
Technologies/Skills Used: Client Management, Requirements Gathering, JAD Sessions, Risk Mitigation, UAT, IxRS/IvRS/IRT, MS Project-like tool, MS Office, Change Management
Confidential, Dublin, CA
SENIOR SOFTWARE QA ENGINEER
- Responsible for maintaining software quality assurance schedules for specific projects.
- Software quality assurance lead on specific projects and provide work leadership for lower level employees.
- Maintain currency of, and adhere to applicable GMP and ISO 9001 processes and procedures. Abide by state and federal employment laws.
- Develop, refine and execute software test plans based on PRS and intended operating environments in cooperation with product management and the software development team.
- Define software test cases based on PRS and test plan in corporation with product management and the software development team.
- Perform the verification and validation process in accordance with established company procedures based on pre-defined test plans and test cases.
- Support the software development team in identifying hard and software compatibility problems. System level support for Microsoft Windows and other operating systems as well as support relating to third party software (i.e. DiCOM) and equipment like printers, data storage devices, etc.
- Support and instruct less experienced peers with their tasks
Technologies/Skills Used: HPQC, HP ALM, IBM Doors, Confidential /GmP, Agile, MS Project
Confidential, Alameda, CA
SOFTWARE QUALITY ASSURANCE ENGINEER II/VALIDATION ENGINEER
- Ensure that non-product computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. Inspect for adherence to SDLC and our Confidential regulated Quality System.
- Review & Inspect non-product SWQA documentation for accuracy, clarity, consistency, completeness and compliance. Including the following:
- System Specifications/Requirements documents, Validation Protocols, Hazard Analysis & Risk Assessment, Change Requests, Traceability Matrices and Validation Summary Reports.
- Protocol Development (IQ/OQ/PQ), Test Documentation Development, Requirements Documentation Development
- Complete SWQA tasks in accordance with current Quality System Requirements.
- Coordinate own work according to higher-level project schedules. Execute SWQA tasks in a timely and efficient manner.
- Maintain schedule and drive to meet SWQA schedule as aligned with project goals. *Provide feedback and report on results of audit to SWQA lead on audit. Support or participate in software audits as needed for internal or external audits in future. Familiar with Confidential 21 CFR Part 820, ISO 13485, FDA 21 CFR Part 11
- As an individual contributor position: support project from concept through launch but also work as part of a cross-functional team
- Involved in the implementation of HP Quality Center (HPQC), also use Agile PLM (Oracle)
Technologies/Skills Used: HPQC, Agile PLM, CSV-Computerized System Validation, IQ/OQ/PQ, SVR, Requirements Inspection
Confidential, San Francisco, CA
PROJECT MANAGEMENT QUALITY/SDLC
- Project Management for specific Software Product Releases related to the Investment & Finance industry; including specialized Software and Tools used in the Structuring, Analysis, Servicing and
- Processing of Asset-Backed Securities (ABS), Mortgage-Backed Securities (MBS, CMBS & RMBS, CDO (Collateralized Debt Obligations) and other products such as Structured Finance tools and Bond Administration for Investment, Underwriting and Finance professionals
- Analysis and Process related tasks, included identifying problems and bottlenecks in current software process and creating/implementing solutions (i.e. implemented a robust regression testing process which resulted product recalls being reduced)
- Advised Business Analysts on the Requirements Gathering & Requirements Management Process Mapping, Workflow& Dataflow Mapping
- Implemented Lessons Learned / Post Mortem process to Project Management & Business Process
- Created, Advised and Implemented a User Acceptance Testing (UAT) Process
- Performed software testing on major software products (related to mortgage-backed securities)
- Interviewing of QA team members and involved in the selection process
- Involved in Jira Implementation