Kimberly-Clark is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 57,000 employees worldwide and operations in 36 countries, Kimberly-Clark posted sales of $20.8 billion in 2011. Kimberly-Clark’s global brands are sold in more than 175 countries. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.
As a global company, we are committed to cultivating a fair, respectful and engaging work environment that inspires our diverse global team to thrive professionally and contribute to the communities where we operate. We also have a responsibility to attain a deeper understanding of our impact on the world. Addressing Sustainability issues and incorporating solutions through all levels of Kimberly-Clark is a critical component of our business.
Location: Neenah or Roswell Offices:
Travel: Approximately 50% of time; with international travel.
Senior Manager - Global Quality Audits - Life Sciences/ Medical Device
As a member of the Global Quality Assurance, you will be an integral part of the process for leading the audit team in performing both internal (K-C facility, business unit or support function) and external (K-C Supplier, Service Provider) manufacturing process/product design engineering and quality systems audits at facilities regulated by drug, medical device, cosmetic and/or consumer product regulations. In addition, you will provide strategic and tactical vision, leadership to initiate, develop and implement effective quality systems by ensuring the application of quality and regulatory systems in compliance with internal and external requirements.
- Manages self and/or team in accordance with the expected behaviors of the Kimberly-Clark Leadership Qualities. Provides work direction and coaching for 3-5 audit team members.
- Provides leadership for quality system development, projects and procedures which ensure effective Safety and Quality behaviors and practices.
- Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported including managing self and team in accordance with the One K-C Behaviors.
- Assures team members effectively develop, evaluate and audit technical quality assurance processes and procedures.
- Ensures activities and systems are in compliance with both company quality assurance standards and applicable government regulations.
- Ensures that the production, process, industrial, environmental, quality system controls and activities are in compliance with both company standards and applicable US and international government regulations.
- Conducts independent manufacturing process and quality system audits to assess compliance to applicable engineering and regulatory standards.
- Reviews corrective action plans to ensure root-cause analysis and proposed actions are appropriate.
- Prepares and approve audit reports and summaries that document compliance status and associated risk to Kimberly-Clark leadership.
- Provides professional expertise and/or support for K-C facilities, contractors, suppliers and/or other functional teams to assist them in engineering and implementing their Quality strategies as well as production process improvement and validation programs.
- Leads manufacturing facility/process and Quality projects of moderate size and complexity or performs as a team member on a more complex project.
- Provides training in areas of specific engineering expertise for our internal customers.
- Provide practical solutions to any manufacturing or quality management issues observed.
- Maintains state of the art knowledge in industrial, process, environmental, mechanical and/or quality engineering as well as drug and device regulatory related fields.
- A Bachelor’s degree in a relevant discipline (Life Science, Quality Engineer or Engineering)
- Minimum 10 years' experience in an FDA regulated business or facility in leadership or management roles.
- 5 to 10 years of experience in at least two related fields e.g. Manufacturing, Quality Control, Quality Assurance, Research, Process Validation, Regulatory Affairs or a closely related field.
- Proven experience in performing audits and receiving audits from regulatory agencies and/or other organizations (e.g. US FDA, ISO, other national regulatory agencies).
- Proven ability to work effectively with and influence business quality leaders. Develops and maintains strong networks across K-C with appropriate teams so that quality best practices can be developed, shared and implemented effectively.
- Strong verbal and written communication skills. The ability to communicate effectively to audiences from the shop floor to General Management.
- Demonstrated ability to train, provide practical and actionable counsel and build capability in business partner teams.
- 10+ years’ experience in an FDA regulated Medical Devices or Pharmaceutical business or establishment.
- Working knowledge and experience with relevant European Union Directives (e.g. Medical Device, Personal Protective Equipment, and Cosmetics etc.), Canadian requirements/standards, other prominent national Quality requirements/standards.
- Significant experience with ISO 9001, 13485, 17025 and requirements and certifications and CE marking requirements.
- Certified Lead Quality Auditor certification or equivalent.
- Previous leadership experience beyond the Quality Engineering/Quality Assurance or Regulatory function (e.g. Manufacturing or R&D).
- Previous experience in Supplier Quality Management, Supplier Auditing and Supplier Qualification.
- Fluency in a second language beyond English.
- An advanced technical degree in an engineering or scientific discipline or MBA.
Kimberly-Clark makes the essentials for a better life with well-known brands that matter every day – at home, school, work and on the...