Kate Sigite Theil Email & Phone Number

St. Louis, Mo, Us

Edwardsville

Overall responsibility for program P&L to ensure strong financial performance.Ensures customer satisfaction and SLA’s are met.Ongoing continuous improvement in both value to the customer and financial/operational performance.Maintains communication with client executive sponsors.Incremental business development to extend the program and/or identifies new business opportunities with the customer.Manages schedule, scope and milestone performance of the program.Manages the day-to-day program/projects as needed to grow the business.Manages major issue resolution and risk mitigation.Manages WWT cross functional issues. Ensure all functions within WWT are performing to program expectations.Interacts with Program customers and vendors.

Greater St. Louis Area

Plan and deliver all stages of the project within a matrix organization, including, but not limited to; the introduction of new products into the facilities, process development, analytical method development and qualification, equipment purchase and qualification, and for overseeing the preparation for, execution of and close out of production batches. Resolve project team issues and facilitate decision making within the team, and drive progress to completion to the required standard (both internally and with the customer) Communicate regularly with the business team, technical team, and customer team. Report on the initially agreed upon customer and internal milestones and share progress, issues, and risks. Track and manage the financial aspects of the project including milestone payments, pass through costs, and FTE estimates to ensure that we are on time and on budget. Develop, improve, and implement program and project management tools and templates for use by the program teams.

Plan and deliver all stages of the project within a matrix organization, including, but not limited to; the introduction of new products into the facilities, process development, analytical method development and qualification, equipment purchase and qualification, and for overseeing the preparation for, execution of and close out of production batches. Resolve project team issues and facilitate decision making within the team, and drive progress to completion to the required standard (both internally and with the customer)Communicate regularly with the business team, technical team, and customer team. Report on the initially agreed upon customer and internal milestones and share progress, issues, and risks.Track and manage the financial aspects of the project including milestone payments, pass through costs, and FTE estimates to ensure that we are on time and on budget.Develop, improve, and implement program and project management tools and templates for use by the program teams.

United States

Provides leadership and experience with review and approval of incident investigations, CAPAs, Change Control documentation, technical memos, regulatory documents and commitments, and adherence to Quality Agreements. Performs the timely disposition of commercial and clinical material to allow shipment to customers, verifies cGMP compliance in raw material usage, accuracy of calculations, execution of steps, and adherence to the approved Quality Agreements, master records and related regulatory filings. Authors and reviews departmental documentation (e.g., Standard Operating Procedures, STPs, and QBRs). Review and approval of validation documentation (i.e. specifications, IQ, OQ, and PQ) related to new facility systems, manufacturing equipment, and analytical equipment.Provides timely QA support to internal manufacturing and technical groups. Manages site Electronic Records Electronic Signatures Program to ensure compliance with 21CFR Part 11 regulations.Manages Change Control subsystem for minor modifications to computer systems, validated equipment and processes.Identifies potential compliance issues and opportunities for improvement to the product disposition system and manufacturing process. Assists in the Implementation of process changes to enhance compliance and improve manufacturing process.

Created/Reviewed/Lead activities related to release/rejection of monoclonal antibody products and raw materials. Reviewed/Approved manufacturing batch records and analytical release testing data according to SOPs, to ensure cGMP compliance, accuracy and completeness. Created and revised SOPs, batch records, regulatory documentation and site documentation. Redesigned batch record review/disposition procedure utilizing operational excellence elements to ensure 100% scheduled disposition and delivery dates. Eliminated procedural requirement of Quality presence during working cell bank thaws to align with industry standards utilizing lean six sigma guidelines.Participated in both internal and regulatory agency audits. Experienced with Health Canada, EMEA, FDA, and Brazilian Health Authorities.

Initiated, coordinated, and completed quality and timely investigations relating to Engineering, Facilities Maintenance and Metrology equipment and facility failures utilizing root cause analysis tools (i.e. fishbone diagrams), as needed. Assisted Quality Assurance Compliance with internal audit inspections, responses; and FDA, Canadian and EMEA health authority inspections. Facilitated Concurrence meetings on Engineering, Facilities Maintenance and Metrology documents. Functioned as a liaison between Engineering, Facilities, Metrology, QA, and other departments, when necessary. Coordinated miscellaneous project teams for the implementation of Manufacturing Excellence (ME2), Kaizen Blitz to reduce the duration of critical maintenance activities for the Metrology department, and 5S methodology activities related to the Facilities storeroom area.

Responsible for explaining and demonstrating Standard Operating Procedures utilizing training plans and assessing competency. Assisting in the creation of training courses and job aids to facilitate learning and performance and to improve compliance. Experienced in facilitating classroom and hands-on training for the production department. Maintaining the training requirements for new and existing employees. Designing and implementing training courses and playing an active role in the St. Louis Training Development Team. Facilitated training including personnel in one-on-one and group settings using training materials, Power Point presentations and hands-on testing and assessments. Created and implemented Power Point presentations to improve the efficiency of people and operations. Trained construction contractors during start-up and shut-down.Assisted with design of curricula for employees.

Associates, Applied Science

Bachelors, Organizational Management