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Experienced quality management and information technology professional with 20+ years of experience with success in dynamic environments along with a strong background within pharmaceutical and other industries. Experienced in Computer System Validation, SDLC, implementing quality processes, technical business systems, maintaining enterprise business applications, managing cross-functional diverse/ global teams, and large-scale technical and quality projects. Equipped with a significant level of communication and interpersonal abilities in addition to a strong knowledge of GxP systems such as event/CAPA management, document management, change control, Complaints Management systems and other quality systems.
Business System Development
21CFR Part 11 and GAMP
Systems Strategy Development
Regulatory Commitments System
Technical Project Management
Data Integrity audit
Infrastructure (Network & Platforms)
Complaints Management System
- Recognized for the successful completion of several consent decree commitment related projects for process re-engineering of Quality systems, ensuring continued compliance and validation of the systems
- Led high-priority, strategic initiatives and increasingly responsible positions from Testing, Technical leadership, Project Management, Systems Analysis to Quality Assurance and Compliance roles for IT systems
- Coordinated technical and quality assurance functions within the organization which includes reviewing and validating activities along with leading the development of new policies and procedures
- Oversee third-party vendors in support of system validation projects, review technical validation documents, and conduct detailed risk assessments
- Work closely with regulatory agencies and corporate partners, audit computerized system vendors, and streamline current quality processes to improve operational efficiency
- Maintain an expert level knowledge of regulatory compliance requirements and project management best practices in addition to implementing continuous improvement strategies
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- Directed complex technical and logistical functions which included monitoring several internal business systems which were responsible for documental control, compliance, and validation
- Analyzed current business process, selected automation tools, developed, maintained and trained users on EDM, RCTS and EInfotree Systems to ensured compliance with quality/regulatory requirements.
- Played an integral role in the integration of EDM to compliance wire which resulted in streamlining internal training processes and improving efficiency
- Assured systems remained in a validated state and under change control to ensure alignment with current business, IT system development lifecycle methodology and regulatory requirements in addition to troubleshooting and investigating system issues
- Promoted to help lead several IT quality systems projects for Consent Decree remediation and support quality system improvement plan and standardization
Reviewed and approved all SDLC validation documentation and ensure the systems are built in a compliant manner along with creating SDLC validation documentation as needed
- Implemented Event Management/CAPA Assessment Programs and developed SOP s and work instructions.
- Provided QA review and approval support on projects as required and created a data integrity audit checklist.
- Accountable as a technology lead for day to day management of the internal TrackWise system implementation which required developing appropriate software business process applications, maintaining current processes, and overseeing data integration processes
- Oversaw the development and management of various systems such as events, deviations, investigations, CAPA, audit management, commitment tracking, EH&S, and change control processes. Lead integration with SAP R/3. Developed and maintained a Complaints Management system for global roll-out
- Facilitated the standardization of quality system processes with a focus on maintaining alignment with internal best practices, maintained internal budgets, supervised a cross-functional technical team during the build of a ETS-Trackwise Global system, and managed the integration of the ETS-Trackwise system into existing quality systems.
- Developed SDLC validation deliverables for a pilot trackwise implementation for a 21CFR part 11 compliant Deviation Management system and Audit Management.
- Assisted users with an event management system which included analyzing software requirements, determining business needs, and documenting of the requirements specifications for process automation and MRP (Mfg.-Pro) system integration.
- Maintained a keen knowledge of the software development lifecycle which resulted in consistently meeting project deliverables and successfully planning a new system rollout
- Performed system testing in order to ensure functionality, monitored compliance, performed disaster recovery testing, and managed the change control board for the system.
- Vendor Management responsibilities to ensure agreements are in place and to ensure required functionality is built in the system.
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- Directed several technical and system support functions within a fast-paced environment with a focus on increasing system productivity and overall efficiency within the entire organization
- As a member of the Consent Decree Commitment Team, Supported the development and deployment of a portal for 14 Manufacturing sites by integrating disparate MRP systems for Where Used Where Made global queries.
- Played a lead role in the implementation of a reference standards management system used by the global quality group which included a web-based inventory enterprise manager and document manager
- Assisted in the implementation of a web-based stock keepers system, a complaints management, deviation, and CAPA management system, and an environmental monitoring LIMS system
- Assisted as a Quality Assurance reviewer and approver for some of the laboratory and spreadsheet validation systems. Conducted 21CFR part 11 audit for laboratory systems (Empower)
Additional Professional Experience available upon request: Held several positions across multiple companies
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