Senior Consultant- Global Product Supply Quality Management Job Description SUMMARY OF POSITION: This role is responsible to provide leadership to the KCP Product Supply’s Thin Mill Glove based products supporting both Industrial and Scientific Business in regards to manufacturing systems compliance with Kimberly-Clark Quality Management System, and applicable government regulations, standards, and company policies and procedures. This role is accountable for setting quality objectives, actively monitors key processes and defines improvement opportunities through quality planning, training, best practices sharing and CAPA process.
Incumbent ensure implementation of GMP and support the growth plans for the KCP business. ORGANIZATION: This position reports to the Quality Leader – Asia Pacific.
The position has a strong indirect relationship with the KCP Product Supply and Regulatory teams.
The incumbent must be able to effectively organize and lead multifunctional teams in providing quality guidance. Customers: KCP Product Supply Leadership, KCP regional Safety and Global Scientific Business Leadership and KCP external manufacturers. GENERAL EXPECTATION and ACCOUNTABILITY: * Be able to successfully lead teams by positively influencing people at all organizational levels * Demonstrates safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss * Manages self and / or team in accordance with the expected behaviors of the Leadership Qualities * Ensures activities and items are in compliance with both company quality assurance standards, and applicable government regulations, such as but not limited to GMPs, OSHA, and ISO requirements * Provides guidance on advanced Quality Engineering practices to cross functional team members. * Establishes and maintain good customer rapport, while driving solutions to meet business needs * Develops, and maintains a strong spirit of partnership * Conducts all communication, and transaction with the utmost integrity * Communicates fully with superiors, teammates, and others who have a need to know. * Provides technical leadership in solving challenging technical problems related to quality issues and technologies * Develops, initiates, and implements new quality concepts, tools and strategies to improve business practices * Provides expertise guidance in specific field of knowledge * Assists with the transfer of knowledge of technical skills * Subject Matter Expert in Design Quality, Process Validation, and Risk Management KEY RESPONSIBILITY: * Develop quality plans and programs for KCP thin mill Contract Manufacturer based on up-to-date quality principles and KCP Product Supply objectives and assure established quality plans and programs are realized. * Provide consultation, guidelines and training to manufacturing facilities in developing and implementing effective quality management system. * Routinely assess the health of facility quality systems and drive gap closure activities. * Assure KCP Quality Systems are utilized as a framework in mills manufacturing KCP products. * Closely partnering with the KCP global quality leadership around the world to identify manufacturing quality system gaps and opportunities for improvement. * Represent KCP in internal and external audit for product quality design and manufacturing systems. * Provide strategic direction for mills in interactions with regulatory agencies and notified bodies. * Partnering with Contract Manufacturers Quality Leader to initiate step change improvement activities associated with manufacturing process, including product sampling, product acceptance, non-conforming product and cost of quality analysis * Act as the Operations Quality Technical Leader to build team capability, provide coaching and work direction to team members with regards to quality matter. * Perform internal and/or supplier quality system assessments to support development of internal, plant or customer capability and compliance. * Build and maintain state of art capability in QMS, ISO and GMPs. * Provide leadership and direction for the Customer Complaint Investigation system for Product Supply so that customer issues are investigated in a timely and effective manner. * Lead and direct high level CAPA activities. * Deliver complete and accurate information to management when critical quality decisions are required. * FORCE/Freeing Up Resources – Support KCP’s Cost Transformation Plan by working with the global suppliers and the staff business teams to ensure the quality engineering is optimized to support cost transformation efforts through reduction in cost of quality. * Quality improvements – Work heavily with suppliers and staff resources to develop and prioritize activities/projects that will optimize process capability to achieve quality improvements. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTION: * Communicate fully with superiors, subordinates, and others who a have need to know. Be informative without being obtrusive and vexatious. Communicate in a way that is timely, yet prompt; complete, yet precise; candid, yet accurate; and clear, yet responsive. * Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results. MINIMUM REQUIREMENT: Qualification/Education/Experience Required: Education required/ preferred: Bachelor in Engineering required Experience: 5+ years working experience * In quality assurance and quality engineering field with in-depth knowledge of ISO 9001, ISO 13485 and 21 CFR 820 * In manufacturing field with medical devices with preference in medical glove * With multinational companies, and experience of collaborating with remote multi-functional teams including business, marketing, manufacturing and research functions Critical: Skills/Qualifications: * Statistical analysis skills * Strong interpersonal skills with the ability to work well with cross-functional team * Efficient, well organised and flexible with the ability to effectively establish priorities, and produce accurate work in a fast-paced environment with minimal supervision * In-depth knowledge of applicable regulatory requirement for thin mill glove.
Preferably having basic knowledge relating to regulated products, and APAC regulatory requirement * Six Sigma certified black belt or green belt, ASQ-Certified Quality Engineer, Certified Quality Auditor, Certified Quality Manager and ISO 9001 or 13485 Lead Auditor Certification preferred. Important: Skills/Competencies: * Ability to drive collaboration across businesses and functions with minimum supervision * Demonstrates personal credibility through strong communication skill, achieving result, and trusted relationship with others * Demonstrates contagious positive energy to promote employee engagement and drive result * Demonstrates passion to drive change and challenge status quo * Demonstrates ability to lead implementation and contribute to the development of vision and strategy * Strong analytical and abstract thinking skills * Cross cultural effectiveness Other Skills: * Demonstrates problem solving skill * Demonstrates facilitation skill * Demonstrates business intuition skill ORGANIZATIONAL RELATIONSHIPS/SCOPE: * Direct reports: Nil * Specific responsibilities and duties may vary widely. WORKING CONDITIONS: Incumbent will be based in South East Asia with a strong preference to Malaysia but will support technology and supply chain optimization globally.
Travel requirements are estimated to be 20%-50%. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Global VISA and Relocation Specifications: Primary Location Malaysia - Petaling Jaya Additional Locations Worker Type Employee Worker Sub-Type Regular Time Type Full time
