This position is responsible for the Quality Assurance aspect of the Quality Program at Kimberly-Clark’s GMP regulated Baby Wipes manufacturing facility in Maumelle, AR. This leader will play a strong role in the Baby Child Care (BCC) sector to influence and drive improvements while ensuring quality compliance and standardization across the sites. This individual shall provide confidence that the quality requirements for the facility will be fulfilled by ensuring that quality is built into our processes and procedures and that quality is a core value in the workforce culture and behaviors.
Customers / Stakeholders
Quality, Safety, Operations, Engineering, Maintenance, BCC Quality, Global Quality Assurance, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Planning, Vendors and Suppliers, End Users of products.
This is a leadership role in the Quality Organization at the Maumelle Baby Wipes manufacturing facility. The QA Leader reports to the Maumelle Quality Senior Manager at the site and is responsible for a team of 6 – 10 employees (mix of hourly and salary).
The Quality Assurance leader provides technical leadership, consultation, coordination, and direction for all Quality Assurance aspects within the facility’s quality management system and reports directly to the Site Quality Manager. The Quality Assurance leader sits on the Quality Leadership team for the site, working in conjunction with the Quality Control leader, the Quality Management leader, and Document Control to ensure the manufacture of formulated Wipes products meet required quality specifications and all applicable corporate and regulatory standards.
This leader must be process oriented and ensure that the following compliance elements serve to build quality into our products:
- Quality Management System (QMS) 3.0 Compliance
- Site BCC Internal and External Audit Processes
- Food and Drug Administration (FDA) Regulatory Audit Readiness
- Plant Hygiene Program and Sanitary Manufacturing compliance
- Validation Management and Responsibility
The manufactured product (Baby Wipes) has the highest microbiological and brand equityrisk within Kimberly-Clark, due to the wet, formulated nature of the product and the consumer requirement to be clean and safe for baby. This leader must recognize the risks and assure that the processes within the mill protect the product for our end consumer.
The supported infrastructure and systems include: water purification systems, formulation batching/blending systems, eight (8)+ wet converting lines, two (2) raw material lines, air handling systems, and a microbiological laboratory. A number of these systems require substantial upgrades over the next 2-4years.
The Quality Assurance Leader is responsible for providing direction and building the capability for the assurance team of 6 – 10 employees. The Quality Assurance team includes, but is not limited to, auditor(s), hygienist(s), and validation engineers. He/She must be able to work autonomously with minimal direction, while ensuring alignment and collaboration with the Site Quality team and the Staff quality teams to define and implement new strategies, per business unit objectives. This leader must be an agent for change, comfortable to challenge the way things have been, in order to drive improvements in the Quality space and ensure that our Quality Program becomes best in class.
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.
- Own all Quality Assurance activities for the site.
- Manage internal audit program through development of internal auditschedules; execute audits and manage related corrective action plans. Ensure audits are prioritized and aligned with objectives and strategies.
- Manage self and team in accordance with the expected behaviors of the Leadership Qualities. Effectively achieve results that meet business and individual objectives.
- 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.
- Ensure established manufacturing inspection, sampling and statistical process control procedures are followed. Perform production and quality system audits.
- Ensure effective quality training is developed and executed to build talent and capability; benchmark with BCC/Global Quality Assurance (GQA) standards. Assist with training.
- Demonstrate a strong knowledge and understanding of Sanitary Manufacturing requirements with regard to water purification, air handling, hygiene requirements, and gowning.
- Provide clear direction for development of Validation Management Program, as required by a Cosmetics type of regulated environment.
- Facilitate Lean problem solving; complete trend and problem analyses for cross-functional team collaboration. Create an empowered culture of accountability and teamwork with strong site/staff networking.
- Conduct performance reviews and ensure team has critical support/skills for development. Quality system areas of responsibility include, but are not limited to, hygiene, auditing, sanitary manufacturing, validations, and supplier certifications.
- Demonstrates, maintains, and builds both personal and team capability in Quality Management Systems (QMS), Good Manufacturing Practices (GMPs), and applicable regulations to support objectives.
- Support Maumelle Quality Team LSW and leadership backup for planned and unplanned events.
- Self-motivated. Positively influence cross functional team members to achieve required objectives.
- Establish and maintain good internal K-C customer rapport, while driving solutions to meet business needs.
- Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, team members, and others who have a need to know.
- Bachelor's degree in a science, engineering, or related discipline with a minimum of 5years’ experience in Quality, Regulatory Affairs, and/or a regulated product Manufacturing environment.
- Knowledge of quality system requirements for Consumer, Cosmetic, and OTC Drug/Pharm or Medical Device products.
- In-depth knowledge and practical experience with Quality Assurance requirements for consumer products and applicable regulatory requirements for cosmetics is required.
- Demonstrated knowledge of GMP regulations and good documentation practices is required.
- ASQ CQA Audit Certification or equivalent (e.g. ISO Certified Auditor, etc.).
- Working knowledge of GMP’s, CAPA, and Validation
- Proven ability to work effectively with and influence business quality leaders.
- Proven ability to drive change within a team or organization.
- Practical knowledge on risk management processes, statistical data analysis, and change control.
- Working knowledge of electronic document and record control systems (e.g. ETQ or equivalent), GMPs, ISO standard and CAPA processes.
- Strong verbal and written communication skills.
- Strong Excel and Word computer skills.
- Must be able to travel (approximately 10%).
- Industry recognized Quality Associate and/or Engineer are highly recommended.
- Demonstrated ability to train and build capability in cross functional and business partner teams.
- LEAN6-Sigma certification – Green Belt or Higher
- Prefer a variety of experience in manufacturing operations, processing, sanitary manufacturing, validations, engineering, and/or business experience beyond Quality