Kate Leith Email & Phone Number

Austin, TX, US

United States

ELIQUENT is the powerful alliance of six global consultancies: Validant, Greenleaf Health, DataRevive, Oriel Stat-a-Matrix, IDEC, and RApport. The collective capabilities of this unmatched alliance enable integrated solutions that bridge the spectrum of regulatory challenges. Together, ELIQUENT Life Sciences sets a new standard for regulatory consulting.

Honored to lead the best team for medical device quality and regulatory consulting. We help enhance patient outcomes and quality of life. Our training and consulting support assists our medical device clients in designing and manufacturing their products and bringing them to market more quickly, effectively, and efficiently. Products such as improved hip.

Oriel STAT A MATRIX provides best-in-class training and consulting solutions - including Regulatory Affairs and Quality Assurance support for Medical Device, IVD and Combination Product Manufacturers.Helping Medical Device and Pharmaceutical organizations succeed in all aspects of Design, Manufacturing, Clinical, Quality, Regulatory, and Compliance.In.

I'm now responsible for all our training services, integrating the Performance Excellence and Lean Six Sigma practices with the core Life Science practice from a global education perspective, We had a successful year of tactical improvements in updating the core Life Science courses and on-boarding several excellent new instructor affiliates. In the coming.

• Oriel STAT A MATRIX provides best-in-class performance improvement training and consulting solutions - including FDA-regulated services, implementation of ISO 9000, and continual improvement methods such as Lean Six.
• Manage the development of customized Life Sciences and Medical Device training courses, working with client companies to understand and address their training needs in all facets of quality/regulatory, problem-solving.
• Manage the updating of existing Life Sciences training courses, including courses in auditing, validation, CAPA, risk management, complaint handling, root cause analysis, regulatory submissions, and QSR/ISO, ensuring.
• Deliver customized and public training. Train and support other instructors to develop their classroom management and presentation skills.

Chaska, MN

• Manage staff of seven investigators with responsibilities including intake and triage of customer complaints, complaint evaluation and investigation, data collection and trending, vigilance report writing (eMDR 3500-A.
• Led the reduction of a major compliance risk from a 38% exposure to less than 5% within 2 months of assignment.
• Provide voice of customer feedback to design control, risk management, and CAPA systems.
• Interface with internal, second-party customer, and third-party auditors for notified body (GMED, NSAI)
• Manage staff of seven investigators. Identify staff training requirements through needs assessment then design and implement practical,effective learning initiatives, programs, and materials which incorporate key.
• Served in this role one year as individual contributor prior to assuming a lateral line management role.

Chaska MN

• Instructional Design, eLearning content development, Instructor-led training
• Trained field service engineers and customer biomedical technicians in theory and maintenance of immunodiagnostic clinical platforms in US, Asia and Europe. Content areas include electronics, mechanics, fluidics.
• Designed and delivered classroom, video-based and eLearning content based on learner needs analysis and core learning pathways using sound instructional and adult learning strategies that resulted in increased learner.
• Advised and assisted international trainers, conducting train the trainer sessions, providing timely and targeted curriculum content updates. Transitioned technical training capabilities to multiple sites, encouraging.

Chaska, MN

• Project\Program Management specializing in management of external vendors
• Managed Anemia-Inflammation program consisting of a portfolio of 7 products in various stages of feasibility, development and commercialization. Orchestrated product delivery and post-launch activities for new and/or.
• Directed design control, process validation, risk management and regulatory submissions activities for three novel in-vitro diagnostic products.
• Participated in project selection and prioritization, estimation of resources needs, net present value and return on investment. Prepared business case, product justifications, product strategies, definitions and.
• Represented project teams and communicated issues, recommendations and plans relative to project status to executive Business Team and functional managers, ensuring understanding and alignment.
• Introduced PM processes and best practices in managing objectives, deliverables, quality and risks within the scope, schedule and budget of the projects. Coordinated preparation of proposed work statements, design.

• Project leader for a several post-launch product enhancement and improvement projects. The support group is a non-traditional functional area for product enhancements. Required an ability to bring diverse groups.
• Designed and improved complaint resolution processes, increasing the efficiency and coordination of several functional areas involved in product support.
• Served as a technical expert, fielding customer calls as a third line resource and providing support during Medical Device Reporting and Adverse Events activities.
• Managed the development of a company-wide website with real-time updates from various applications (Oracle, Lotus). Small supervisory role (1-2 people).
• Awarded “Circle of Excellence” recognition (<1% of corporation win annually).

Chaska, MN

• Lead developer for a variety of in-vitro diagnostic products. Managed effective design transfer from development to manufacturing. Participated in numerous Continuous Process Improvement projects, including Six Sigma.
• Designed and executed numerous test method and process validation studies, resulting in process capability improvements and smooth technology transfer to operations.
• Ongoing participation in formal mentorship programs continuing to present day. Coach team members according to their needs (skills, alignment and conflict management). Periods of formal supervisory roles (1-2 people).
• Interacted with clinical laboratory directors in study collaborations. Served as principal investigator in clinical trial (in-house), gaining familiarity with Case Report Forms, Good Clinical Practices and clinical.
• Nominated for “Circle of Excellence” Award (approximately 5% of Chaska site nominated annually).

Chaska MN

• Managed cross-functional deliverables for Design Control, Design Transfer and system release for over a dozen new products. Completing this effort while a member of QA demonstrates my initiative and business astuteness.
• Established new design control, development and design assurance methodologies ensuring both efficiency and conformance to product development processes and regulatory guidelines.
• Assisted in gaining ISO 9001 site registration. Performed numerous supplier quality and internal audits.
• Deployed statistical process control, various risk analysis tools (FMEA, FTA etc.), Design assurance reviews, Design of Experiments.

St Louis, MO

• Biopharmaceutical manufacturing. Assay Development, test method validation-Managed technical staff of up to 16 ranging from High School to PhD level in research, product transfer, and quality control. Actively involved.
• Developed, monitored and communicated departmental budgets, metrics and objectives.
• Managed the development and validation of effective analytical strategies to meet the technology and product requirements
• Quality engineer certification (ASQC). Body of knowledge includes extensive quantitative statistical methods, quality system development, problem-solving and improvement, product\process quality and quality management..
• Demonstrated leadership and sensitivity by maintaining morale and efficiency during challenging periods of organizational downsizing and by building staff during expansion.
• Wrote and managed over 50 validations. Established product specifications, sampling plans, trend analyses, equipment monitoring programs, and stability studies.

St. Louis MO

• Performed stat and routine laboratory testing, interacted with physicians and nursing staff and gained understanding of hospital operations and compliance systems.
• Developed radioimmunoassays (RIA) and enzyme-linked immunosorbent assays for a variety of endocrine analytes.
• Supervised technicians in routine analysis of patient samples for university investigators attached to the Core Lab.
• Served as lead escort for hospital and regulator auditors.
• Analysis and design of novel analytical methods for organic and biological materials using a wide variety of wide variety of analytical instrumentation (HPLC, FTIR, GC, PAGE etc).
• Assisted graduate students, post-doctoral fellows and the principal investigator in designing and executing experiments and results interpretation for diabetes and endocrine research.

Master Of Business Administration (M.B.A.)

Education record

Master’S Degree

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