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Principal Statistician - Global QMS

Company: Kimberly-Clark Corporation
Location: Roswell
Posted on: October 13, 2020

Job Description:

Principal Statistician - Global QMS JOB DESCRIPTION PRINCIPAL STATISTICIAN - GLOBAL QMS SUMMARY OF POSITION: The primary purpose of the PRINCIPAL STATISTICIAN - GLOBAL QMS is to provide leadership and direction to establish statistical method standard practice and to ensure appropriate statistical technique development and application throughout the lifecycle of products across the end-to-end supply chain for Kimberly-Clark products globally. The Industrial Statistician specializes in the application of Statistics in Design Control, Manufacturing and Post Market Surveillance programs. The role reports directly to the Sr Manager, Global Design Controls. ESSENTIAL ACCOUNTABILITIES: * Serves as the Global Quality Management Leader with authority and accountability for developing, deploying, and maintaining the statistical methods standard practices throughout the quality management system (QMS) for the design, risk management, and ongoing life cycle management of K-C products. Sets and oversees the global standards and tools related to statistical methods. * Provide statistical oversight enterprise-wide to assure regulatory compliance across the end-to-end supply chain ensuring conformance to cGxPs, guidance documents, and applicable industry accepted standards. * Responsible for the accuracy and appropriateness of statistical inputs (e.g., statistical methodology, protocol design, interpretation of results and inference) provided for quality management activities in design control, manufacturing and post-market surveillance ensuring regulatory compliance. * Develop Global Design of Experiments & Statistical Problem Analysis/Solving frameworks to use within quality plans, design transfer, design verification/validation, and process validation enabling fact-driven statistically based decision making where appropriate. * Provide strategic thought leadership in statistics and actively facilitate and/or participate in the development of deliverables required for quality management in new product development, product design changes, validation, investigation problem solves and root cause analysis. * Serves at the subject matter expert for statistical methods in quality and leads statistics-related aspects of significant projects. * Participate in or lead team in problem solving activities to determine root cause and appropriate actions. * Lead statistical evaluations such as change point analysis, specification establishment, acceptance sampling plan establishment. * Carry out all activities according to appropriate procedures, working within the framework of the Quality Management System. * Ensures statistical methods and practices are in compliance with current regulatory regulations and guidelines. * Establish and lead the Quality Statistical Methods Center of Excellence (COE) and Champion Network and builds statistics capability enterprise-wide. * Effectively mentor less experienced statisticians, quality engineers, and scientists. Provide formal training to statisticians and non-statisticians. * Ensure Inspection Readiness of assigned area and provide active support during regulatory agency and third-party inspections. * Maintains subject matter expertise and comprehensive knowledge of applicable current and emerging regulatory requirements. * Builds and maintains strong relationships and networks with key stakeholders and peers within the business unit, across the enterprise, and across industry. * Influences and engages at all levels of the organization. GENERAL EXPECTATIONS AND ACOUNTABILITIES: * Manage self in accordance with the expected One K-C Behaviors. * Lead and/or oversee tasks such as recruiting, onboarding, training, talent management etc. Provide feedback, coaching and direction to team leaders and team members. * Builds capability in self by maintaining and demonstrating a high degree of knowledge and skill in quality management systems, quality engineering, risk management processes and regulations. * Establishes and maintains collaborative relationships while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership. * Conduct all communications and transactions with the utmost integrity, consistent with the KC Code of Conduct. Communicate fully with Senior Leaders, Peers, Support Partners etc. with matters that are appropriate. * Travel up to 25% of the work time. BASIC QUALIFICATIONS: * Doctoral degree in statistics or Master's degree with sufficient relevant experience. * 10+ years of experience in a statistician role in a medical device, pharmaceutical or similar environment with experience in a larger organization. * A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer. * Advanced knowledge of statistical application and methods for medical devices and/or pharmaceutical industries. * Ability to apply advanced knowledge of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, and change point analysis. * Advanced knowledge of common and highly complex statistical theory and methods, design of experiments (DOE), experimental design, descriptive and inferential statistics, and computer systems. * High degree of technical competence and communicative ability, both oral and written. * Ability to explain statistical concepts to non-statisticians. * Ability to work to tight deadlines while maintaining high standards. * Working knowledge and experience with products requiring compliance with various regulatory or other technical requirements. * Proficient with at least two statistical software packages. PREFERRED QUALIFICATIONS: * Experience in an organization with Quality as a compliance function. * Understanding of key regulations and standards applicable to K-C specifically related to medical devices. * A minimum of 5 years as a lead statistician leading the development and application of efficient and effective statistical solutions across multiple disciplines. * Good knowledge of product development and commercialization process and relevant regulatory guidelines. * Existing and Emerging Health Authority policy expertise. THIS POSITION IS LOCATED AT K-C FACILITIES IN ROSWELL, GA OR NEENAH, WI USA. Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark. For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law. The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position. This position may require a post-offer/pre-hire Physical Abilities Test (PAT) to confirm that individuals are able to perform the essential functions of the job. K-C requires that an employee have authorization to work in the country in which the role is based. In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization. However, based on immigration requirements, not all roles are suitable for sponsorship. This position is subject to drug and alcohol testing, including pre-employment testing. GLOBAL VISA AND RELOCATION SPECIFICATIONS: K-C will support in-country relocation for the chosen candidate for the role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C's applicable mobility policies. The benefits/policy provided will decided in K-C's sole discretion. This position is subject to drug and alcohol testing, including pre-employment testing. PRIMARY LOCATION USA-GA-Atlanta-Roswell ADDITIONAL LOCATIONS USA-WI-Neenah WORKER TYPE Employee WORKER SUB-TYPE Regular TIME TYPE Full time

Keywords: Kimberly-Clark Corporation, Roswell , Principal Statistician - Global QMS, Other , Roswell, Georgia

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