Experience

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  Purolator products, inc.

  Jan 1985 - Jan 1987

  Marketing analyst

  Wrote SAS programs to provide buy back estimates for inventory for clients changing to our brand. Maintained price databases.

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  Deloitte, haskins & sells

  Jan 1987 - Jan 1988

  Programmer analyst

  Responsible for development, maintenance and documentation of systems to create operating statistics reports and graphs, partner database, business plans, and consolidations. Responsible for determining software and hardware needs.Designed three year business plan and forecast models for audit, tax, small business and consultants to management departments for firmwide distribution and consolidation.

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  Smith barney

  Jan 1988 - Jan 1990

  Programmer analyst

  Responsible for hardware and software support for Accounting Dept. with 100 people. Determined hardware and software needs. Designed network based accounting systems. Administered a Banyan Vines network with 50 users.Designed numerous systems to automate manual processes such as primaries interest analysis, cash advances, free rent, labels, amortization.

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  Dzs computer solutions, inc.

  Jan 1991 - Jan 1997

  Senior programmer analyst

  Developed data entry systems including remote data entry for several phase II/IV drug studies.Developed more complex diagnostics to isolate inconsistent and incomplete data. System generated errors and warnings.Worked on the design, development, testing and implementation of various portions of SYMVEX, a system for processing and tracking clinical data for the pharmaceutical industry.

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  Dzs software solutions, inc.

  Jan 1997 - Jul 2017

  Quality assurance manager

  * Oversaw the software development lifecycle, ensuring quality in the delivery of applications such as Coding, CTMS, Data Management, and Reports.* Developed, executed, and reviewed test plans; designed templates for use in the SDLC.* Managed the creation, review, and approval of Policies and SOPs to maintain regulatory compliance.* Conducted in-depth research on FDA regulations (including 21 CFR Part 11) to ensure product and process compliance.* Performed risk assessments to enhance software quality and minimize potential issues. Show less

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  Anju software

  Jul 2017 - now

  * Helped bring Clinical Trial Management Software (CTMS), Electronic Data Capture (EDC), Electronic Trial Master File (eTMF) and other SaaS and/or cloud products to market by review and approval of SDLC documents created as part of CSV activities.* Managed the lifecycle of documents such as Policies, SOPs, Standards, and Work Instructions in Dot Compliance, electronic Quality Management System (eQMS), from creation through retirement. * Conducted risk assessments and reviews of the new eQMS validation documentation ensuring compliance with industry standards and CSV.* Developed and implemented the creation of new quizzes, templates, and protocols within Dot Compliance.* Served as the product Compliance SME, during the Clinical Trial Division audits, partnering closely with the Audit Manager. Audited the company's internal processes.* Conducted internal audits and assessments for compliance with regulations: 21 CFR Part 11-Electronic Records; Electronic Signatures, GCP, Personal Information Protection and Electronic Documents Act (PIPEDA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).* Conducted internal assessments for compliance with guidances: Computer Software Assurance (CSA) aand the General Data Protection Regulation (GDPR) Show less * Administered the Quality Management System (QMS), overseeing the management of Policies, SOPs, Standards, and Work Instructions in PolicyTech (NAVEX).* Helped bring Clinical Trial Management Software (CTMS), Electronic Data Capture (EDC), Electronic Trial Master File (eTMF) and other SaaS and/or cloud products to market by review and approval of SDLC documents created as part of CSV activities.* Validated PolicyTech, maintaining the system's integrity and compliance with regulatory standards. * Maintained SOPs, and Work Instructions for eQMS.* Managed the creation and feedback process for system quizzes, improving their overall quality.* Played a key role as Product Compliance SME in organizing and supporting Clinical Trials Division audits.* Facilitated the merger of QMS documents from acquired companies, ensuring seamless integration. Show less

  • Senior Manager, Compliance

    Aug 2023 - now

  • Quality and Compliance Manager

    Jul 2017 - Aug 2023