This position is the Quality Management Representative responsible for the Quality Management System (QMS) for the Maumelle, AR regulated product manufacturing facility. It provides technical leadership, consultation, coordination, and direction for facility quality control systems to ensure the manufacture of formulated Wipes products meet required quality specifications and all applicable corporate and regulatory standards. The scope of responsibility and influence includes Quality Assurance, Quality Control, Quality Management, Validation Management, and Sanitary Manufacturing requirements. The position will oversee significant upgrades to facility quality systems and infrastructure to reduce risk and must be able to drive change in mindsets and behaviors across all levels of the organization. This position will establish and manage quality improvement projects in accordance with company goals and objectives and work with cross-functional teams to ensure appropriate controls and documentation relating to QMS requirements are followed.
Mill Operations & Engineering, Product Supply, BCC Staff and Global Quality, Research, Engineering, Marketing, Legal, Purchasing, Logistics, Regulatory Affairs, External Regulatory Agency contacts, End Users of products.
The incumbent reports to the Maumelle Mill Manager.
Responsible for the QMS for manufacturing of a regulated product (Baby Wipes) with the highest microbiological and brand equityrisk within Kimberly-Clark, due to the wet, formulated nature of the product and a highly sensitive and vocal user base.
This critical leader shall provide leadership for the significant upgrade of the mill’s quality systems, infrastructure, and procedures. He/she shall drive change to mindsets, behaviors, and capabilities to build an empowered Quality Culture throughout the mill, at all levels of the organization. He/she shall challenge the current methods in order to drive innovation and excellence within the Quality space. This leader must demonstrate ability to mitigate historical and emerging risks (1-2 crises per year, with $20MM sales loss), and ensure that finished product quality meets FDA regulatory and corporate guidelines.
The Quality Senior Manager is also responsible for providing direction and alignment for and building the capability and knowledge of the Quality group of 15 – 20 team members, 4-8 of those being direct reports. The Quality team includes team leaders, technicians, microbiologists, hygienists, and validation engineers. He/She must be able to work autonomously with minimal direction, while ensuring alignment and collaboration with the Staff quality teams to define and implement new strategies, per business unit objectives.
The supported infrastructure and systems include water purification systems, formulation batching/blending, eight (8)+ wet converting lines, two (2) raw material lines with historical high-risk for complaints/crisis events, air handling systems, and a microbiological laboratory. A number of these systems require substantial upgrades over the next 2-4years.
General Expectations and Accountabilities
- Demonstrate 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 team in accordance with the expected behaviors of the KC-One Behaviors. Effectively achieve results that meet business and individual objectives.
- Drive change and inspire a team to reach new levels with regards to the Quality Culture and Program.
- Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.
- Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know.
- Execute continuous improvement activities for established processes and initiates development of new processes.
- Acts as the Quality Management Representative for the Maumelle Facility.
- Ensures the facility maintains adequate systems, personnel, and infrastructure for Quality Assurance (including Microbiological Lab), Quality Engineering, and Supplier Quality Management, to support compliance and meeting organizational quality objectives.
- Acts as the Team Manager, administering performance feedback and salary handling, providing coaching and work direction to team members, recruiting and hiring new team members, and assuring all activities are prioritized and resourced appropriately.
- Ensures activities are in compliance with both ISO9001-aligned company quality assurance standards and applicable government regulations, such as regulated product Cosmetic Good Manufacturing Practice (GMP) requirements. Ensures the facility remains regulatory audit-ready.
- Leads significant Quality Improvement activity to mitigate emerging social media and consumer safety risks – including improvement to Quality Systems as well as facility infrastructure. Initiates and executes continuous improvement activities for established processes, and supports development and implementation of new quality processes.
- Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable.
- Ensures there is a robust Internal Audit system for production and quality systems, with timely resolution of identified problems.
- Ensures there is a robust Corrective and Preventative Action (CAPA) system, with connection to sources of input, and timely resolution of identified problems.
- Leads routine Management Reviews of the Quality System
- Provides Quality system expertise, guidance, and training to key customers and stakeholders.
- Demonstrates, maintains, and builds both personal and team capability in Quality Management Systems (QMS), Good Manufacturing Practices (GMPs), and applicable regulations to support objectives.
- Represents Maumelle Quality in BCC and enterprise initiatives to ensure facility needs are considered and included, whenever appropriate.
- Builds and maintains strong relationships across key Kimberly-Clark functional areas as well as across Kimberly-Clark mills to foster sharing of information, swiping of best practices, and increasing mill expertise to deliver overall KC QMSR and Regulatory compliance.
- Participates in BCC Crisis Management/Prevention meetings or Investigation teams, as assigned.
- Bachelor's degree in a science, engineering, or related discipline; and 10+ years broad experience in a Quality, Regulatory Affairs, or regulated product Manufacturing background.
- Knowledge of quality system requirements for Consumer, Cosmetic, and OTC Drug/Pharm or Medical Device products.
- Working knowledge of GMP’s, CAPA, and Validation
- Experience successfully lead and direct teams, large projects, and influence multi-functional organizations.
- Industry-recognized Quality Manager and/or Auditor certifications
- LEAN6-Sigma certification – Green Belt or Higher
- Diverse background in mill operations, R&D, engineering, or business experience beyond Quality