Internal Control & CSV Global Design Expert
Youre not the person who will settle for just any role. Neither are we. Because were out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, youll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands. In your Internal Control & CSV Global Design Expert role, youll help us deliver better care for billions of people around the world.
The purpose of this role is to support K-C businesses, functions, and ensure operations are conducted in a manner that complies with regulatory and internal control requirements. The Internal Control & CSV Global Design Expert is a hands-on partner with project team members, business teams, and other functional teams to study, evaluate, and complete compliance and control practices and improvements. He or she participates as a member of project teams to complete compliance and control tasks as new processes are developed. This role leads the Computer System Validation work stream for Project Aurora.
Your key responsibilities include:
Lead the development and maintenance of the Computer System Validation Master Plan for Project Aurora, ensuring compliance with all applicable regulations and K-C requirements, and complete task as required.
Work with process owners on requirements and performance of Computer System Validation (CSV). Perform, document, and validate CSV activities as needed, and support knowledge sharing and capability building related to CSV across the project.
Validate highly regulated enterprise level business systems including SAP, Inventory Management System, Project Management Systems, CRM.
Analyze and review validation deliverables like Validation Plans, Risk Assessments, Quality Assurance reviews, and Validation Summary Reports, in compliance with GxP Compliance Regulations.
Work with process owners to ensure that management testing is executed as expected, including updating of master data, evaluation of test results, and development of remediation plans.
Work with process owners to ensure their remediation plans for issues identified appropriately address the relevant risks, and follow-up to ensure remediation is completed timely.
Engage in and lead activities and initiatives to raise the awareness and knowledge level of internal controls and CSV and provide targeted or general training to employees related to their responsibilities.
Review plans for embedding strong internal controls in key projects, to ensure such plans are sufficient to protect the company and in compliance with the companys Corporate Financial Instructions, CSV company standards and regulatory requirements.
Serve as the face of the Controllers Office to the business and project for all internal control and CSV questions, interpretations, or issues.
Perform analyses and special studies as needed.
As the Subject Matter Expert, liaise and represent Computer System Validation with external auditors and regulatory bodies as needed.
Youre driven to perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development.
Required Qualifications:
Bachelors degree or higher in IT, accounting, quality management, or another relevant discipline
3+ years of hands-on experience in auditing or validation with experience in Computer System Validation, Software Development Life Cycle auditing, or Technical Writing, along with performing manual and automated Testing
Experience working in a matrix organization, working closely with the business to align IT Services and business strategies, demonstrating strong leadership skills
Excellent relationship management skills and leadership skills, and the ability to engage business team members using business and industry terms
Outstanding collaboration, influence, and communication skills
Ability to work independently
Well versed with MS Office
Preferred Qualifications:
Full validation life cycle experience including developing and maintaining SDLC for validated systems, Validation Plans, and validation reports
Hands on experience in manual testing of various applications and developed test plans, deliverables, entry and exit criteria, documentation of User Acceptance Testing based on User Requirements, and assessment of risk and security aspects for computer applications
Involved in all aspects of the computer systems validation lifecycle, in compliance with U.S. FDA regulations
Professional experience in GXP (GMP, GLP, GCP), 21 CFR Part 11, GAMP5 for Consumer Goods Manufacturing
Experience in preparing risk assessments, regulatory assessments, technical assessments, remediation plans, and deviation reports in a regulated environment
Huggies. Kleenex. Cottonelle. Scott. Kotex. Poise. Depend. 25% of people in the world use Kimberly-Clark products every day. And it takes the right people, in the right jobs and the right places, to make that happen.
At Kimberly-Clark, youll be part of the best teams committed to driving innovation and growth. Were founded on 150 years of market leadership, and were always looking for new and better ways to performso what can you do with that? Theres no time like the present to make an impact at Kimberly-Clark. Its all here for you at Kimberly-Clark.
Great support for good health with medical, dental, and vision coverage options. No waiting periods or pre-existing condition restrictions. Access to an on-site fitness center, occupational health nurse, and allowances for high-quality safety equipment.
Flexible Savings and spending accounts to maximize health care options and stretch dollars when caring for yourself or dependents.
Diverse income protection insurance options to protect yourself and your family in case of illness, injury, or other unexpected events.
Additional programs and support to continue your education, adopt a child, relocate, or even find temporary childcare.
Click the Apply button and complete the online application process. A member of our recruiting team will review your application and follow up if you seem like a great fit for this role.
In the meantime, check out the careers website. Youll want to review this and come prepared with relevant questions if and when you pass GO and begin interviews.
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 role is available for local candidates already authorized to work in the roles country only. K-C will not provide relocation support for this role.
#LI-Remote
Replace headcount (Greivin Madrigal)
USA-REMOTE
Argentina -Buenos Aires, EMEA Anywhere, Sao Paulo Office
Employee
Regular
Full time