Alison Schmidt Email & Phone Number

Holly Springs, Nc, Us

Direct the Global Clinical Supply Quality team for all CSL product platforms including Gene Therapy, Vaccines, Recombinant, and Plasma.

Responsible for a multi-disciplinary team including managers and senior professionals providing frontline Quality Assurance oversight of third party GMP sterile vaccine clinical trial packaging and batch disposition of clinical trial material (CTM) globally to ensure compliance with applicable regulatory filings, cGMP regulations and data integrity, and provide QA oversight of changes and deviations

Holly Springs, North Carolina, United States

Holly Springs, North Carolina

Aiken, Sc

Lead a team of quality assurance associates responsible for Supplier Quality, Consumer Complaints, Product Release, Deviation and CAPA management, Periodic Product Review, Quality Council, TrackWise Administration, Recall, Field Alert and Inspection Readiness. Provided sound judgment to set unambiguous and compelling vision for team that contributes to site’s strategy for delivering continuous improvements and products of value with zero defects and waste. Drive improvement in deviations and… Show more Lead a team of quality assurance associates responsible for Supplier Quality, Consumer Complaints, Product Release, Deviation and CAPA management, Periodic Product Review, Quality Council, TrackWise Administration, Recall, Field Alert and Inspection Readiness. Provided sound judgment to set unambiguous and compelling vision for team that contributes to site’s strategy for delivering continuous improvements and products of value with zero defects and waste. Drive improvement in deviations and consumer complaints for primary and secondary packaging investigations. Including leading cross-functional team with quality, operations, planning and procurement to address off-quality issues and identify risk and opportunities for improvement and ensure material and components are received with no defects. Built and ensured a quality unity of critical roles within the quality assurance team, by investing in people and building capability to support the site’s strategy. Provided direction to teams to ensure timelines and milestones are met during remediation of quality systems for Supplier Management, Deviation Management (Local Incident Committee/Product Incident Review Committee), and Quality Council. Implemented GPS (GSK Product System) performance management for quality assurance team to drive accountability and timely escalation/resolution of issues. Develop sustaining relationships with customer both cross departmental and within the Global Manufacturing Supply network by participating on global projects and implementing at site level for global SOPs and Inspection Readiness for harmonization. Lead and managed successful regulatory and customer audits, including FDA, EMEA and ANVISA. Show less

Aiken, Sc

Manage, maintain and enhanced the current site documentation control practices and resources including managing of 2 documentation coordinators and a compliance technician. Serve as site market liaison in the development and maintenance of the following: Technical Terms of Supply, Quality Agreements, Regulatory Registration and Conformance files, Review Regulatory Submissions, Annual Reports, New Product/Market Introductions, develop and maintain database with respect to regulatory activities… Show more Manage, maintain and enhanced the current site documentation control practices and resources including managing of 2 documentation coordinators and a compliance technician. Serve as site market liaison in the development and maintenance of the following: Technical Terms of Supply, Quality Agreements, Regulatory Registration and Conformance files, Review Regulatory Submissions, Annual Reports, New Product/Market Introductions, develop and maintain database with respect to regulatory activities and post approval commitment. Developed and trained on systems to ensure regulatory documentation is received prior to finished product release.Act as liaison for CMO customer for quality management of customer’s product. Manage site risk management system and risk mitigation. Ensured timely closures of site risk. Liaise with plant to address off-quality issues and identify risk and opportunities for improvement. Lead teams to gain improvement in compliant reduction, documentation not Right First Time and compliance with market release requirements. Approve change controls, deviations, customer complaints, validation protocols and reports. Perform trend analysis for product quality attributes and consumer complaints for both domestic and foreign markets. Author and maintain Site Master File and Periodic Product Review. Manage site control room for regulatory inspections. Lead level 1 and 2 internal audits. Manage Aiken Quality Team Site. Report into site Compliance Council and Risk Register. Show less

Support production of flu, meningitis, yellow fever and diphtheria/tetanus vaccine by ensure completion of the annual supplier audit schedule by performing quality audits of key raw material and component supplier and contract partners. Respond to quality issues by performing for cause audits. Communicate findings to internal user groups and quality management, and ensure adequate and timely responses to audit observations. Manage the quality agreement system for the Swiftwater site… Show more Support production of flu, meningitis, yellow fever and diphtheria/tetanus vaccine by ensure completion of the annual supplier audit schedule by performing quality audits of key raw material and component supplier and contract partners. Respond to quality issues by performing for cause audits. Communicate findings to internal user groups and quality management, and ensure adequate and timely responses to audit observations. Manage the quality agreement system for the Swiftwater site. Participate in cross-functional project teams to address supplier-related quality issues and drive supplier quality improvements. Lead supplier performance monitoring program. Assist the Supplier Qualification Board to provide oversight of the supplier change process and qualification of materials. Perform internal audits of Swiftwater’s biological services, formulation, filling, packaging, warehouse and distribution departments. Show less

Manage product quality and compliance for assigned contractors (3rd party). Ensure that quality aspects are built into Quality Agreements and periodically review and revise to meet continuous quality improvement. Advisor to the department as resident Microbiologist on microbiologic issues. Critically evaluate reports, processes and facilities against compliance requirements. Enforce the requirements for process, packaging, method, cleaning, facility and computer validation, stability support… Show more Manage product quality and compliance for assigned contractors (3rd party). Ensure that quality aspects are built into Quality Agreements and periodically review and revise to meet continuous quality improvement. Advisor to the department as resident Microbiologist on microbiologic issues. Critically evaluate reports, processes and facilities against compliance requirements. Enforce the requirements for process, packaging, method, cleaning, facility and computer validation, stability support requirements and the change control process. Review and approve non-conformance reports. Evaluate process capabilities. Define trends and identify undesirable effects within a process to eliminate variation in both process and method that would delay product to market. Support the commercial groups, the approval and launch of new products. Build quality, cost and speed considerations into the development process. Show less

Gained cGMP and knowledge for consumer product testing of microbial contamination of finished product, intermediate product and raw material. Acquired proficiency in LIMs. Supervision of technicians in the testing laboratory to assure completion of incoming test samples and preparation of media. Perform sanitization swabbing for cleaning validation and verification of processing vessels. New product development. SOP revision. Participated in problem solving in collaboration with other… Show more Gained cGMP and knowledge for consumer product testing of microbial contamination of finished product, intermediate product and raw material. Acquired proficiency in LIMs. Supervision of technicians in the testing laboratory to assure completion of incoming test samples and preparation of media. Perform sanitization swabbing for cleaning validation and verification of processing vessels. New product development. SOP revision. Participated in problem solving in collaboration with other departments. Show less

Bachelor Of Science - Bs, Microbiology, General

Bs, Microbiology

Undergraduate Research Assistant, University of Tennessee, Aquatic Ecology Laboratory, Knoxville, TN, Spring 2000. The project involved.