Kathleen Russell Email & Phone Number

Deerfield, Il

Ensure that the GMP quality management systems related to TGRD's global drug development processes contain accurate data and are maintained in good working order. Utilize systems to collect data, analyze these data relative to quality performance of systems and processes, and prepare and issue reports that summarize these analyses along with recommendations for improvement. Serve as primary operational support for global GMP quality systems developed for and utilized by the GIQ (Global Investigational Quality) organization, of which TGRD GMP QA is one of the regional affiliates.

Provide key research operations support within Clinical Pharmacology and Bioanalytical Chemistry departments including document management, vendor management, coordination of internal resources, project tracking and status reports.Created and implemented several databases for multiple departments to assist with study timelines, resource allocation, study documentation, metrics, and bibliographic citations.Developed process for document submission and tracking for Regulatory submissions and non-submission document archival into documentum-based systems enabling rapid retrieval. Functional area representative and departmental trainer for use of multiple documentum-based systems which enabled the departments to remain current with company document processes and proficient with the use of the systems.Organized and managed communications with external vendors for study analysis scheduling, sample receipt, sample and document archives, and reports to insure timelines and contractual obligations were met.Expedited document submission and bibliographic citations to meet timelines for preparation of New Drug Applications (NDA) for FDA submission. Served on teams for numerous special projects. Volunteered as a member of Takeda’s Emergency Response Team. Recipient of Circle Awards for Takeda-TAP Integration and for Kapidex NDA Approval.

Provided key research operations support including document management, vendor management, contract management, invoice processing and payments as well as quality management systems for multiple departments. Liaison with vendors for billing and contract matters.Evaluated and improved departmental processes for contract requests and supporting documentation to ensure compliance with company policies. Received R&D Customer Service Award.Performed quality control reviews of documents and contracts to insure accuracy and version control.Tracked study progress against contract terms and communicated status to management to insure timelines were met.Coordinated corrective and preventive action documentation and tracking to insure compliance with policies procedures and guidelines. Nominate by Senior Management and received R&D MVP Award.Insured necessary departmental documents were submitted in a timely manner in the preparation of NDAs for FDA submission. Received a number of Spot Awards for my efforts. Served as subject matter expert and functional area representative in the development, training and implementation of TAP’s first electronic regulatory submission system. Received R&D Team Player Award for my participation in this project.Participated in numerous special projects. Volunteer member of the TAP Emergency Control Force

Maintained departmental scientific protocol and report files, electronic archival of documents, format and non-technical quality review of reports, contract and invoice management for multiple departments.Developed and managed the process for departmental documents, scientific articles, publications and electronic archival ensuring document availability within the department and for other groups within the company. Received a Spot Award for my efforts.Assessed the need and enhanced study tracking system, project plans and report database. Improved the process for formatting and quality control review of non-technical aspects of reports ensuring document compliance with company policies and version control.Streamlined and managed contract requests, invoices and payments for scientific studies.Volunteer member of the TAP Emergency Control Force and member on numerous committees.