Principal Quality Engineer, Computer Systems Validation

3 years ago

Job Description

SUMMARY OF POSITION:

This position is for a Principal Quality Computer Systems Validation Engineer to work enterprise-wide to develop and deploy strategic quality initiatives, standards and tools. In addition, this position leads the establishment of strategies and validation plans for Computer Systems Validation of local and enterprise-wide computer systems.

ESSENTIAL ACCOUNTABILITIES:

Accountable to lead the Computer System Validation Program. Uses the assessment process to build capability, drive continuous improvement, mitigate risks and ensure compliance to K-C requirements and external laws and regulations.
Contributes to strategy development in the area of Computer Systems Validation of Kimberly-Clark enterprise-wide computer systems.
Define, establish, and lead the implementation of the risk-based CSV program (tools, methods, standards, competency, process and process performance) for software validation and lifecycle control of new and existing systems.
Leads quality system improvement programs to establish, standardize and improve computer system validation compliance to ensure business, facility and corporate objectives are met.
Provide computer system validation and software development oversight enterprise-wide to assure regulatory compliance across the end-to-end supply chain ensuring conformance to cGxPs, guidance documents, and applicable industry accepted standards.
Develop/update validation project plans and computerized system lifecycle program documents to deliver large scale computerized system validation projects.
Manage computer system inventories relative to the master validation plan, perform system validation determinations, change assessments, and provide necessary documentation for regulatory compliance purposes.
Establish and lead the CSV Center of Excellence (COE) and CSV Champion Network and builds capability enterprise-wide.
Ensure that a consistent computer system validation approach for IT infrastructure, Computerized Process Equipment, Manufacturing Computerized Systems, and Labs is used acrossthe K-C enterprise.
Ensure Inspection Readiness of assigned area and provide active support during regulatory agency and third-party inspections.
Maintains subject matter expertise and comprehensive knowledge of applicable current and emerging regulatory requirements relative to computer systems and validation.
Takes leadership and ownership of the computer system validation master plan for computer systems that have enterprise-wide scope and impact.
Serves at the subject matter expert for Computer Systems Validation and lead CSV-related aspects of significant enterprise-wide projects.
Participate in or lead team for Computer Software and Service supplier evaluation, selection, qualification and audits.

GENERAL EXPECTATIONS AND ACCOUNTABILITIES

Manage self in accordance with the expected One K-C Behaviors.
Influence and recommend new quality concepts, tools and strategies for the enterprise Quality organization.
Builds capability in self by maintaining and demonstrating a high degree of knowledge and skill in computer system validation, processes and regulations.
Builds and maintains strong relationships and networks with key stakeholders and peers within the business unit, across the enterprise, and across industry.
Establishes and maintains collaborative relationships while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership.
Conduct all communications and transactions with the utmost integrity, consistent with the KC Code of Conduct. Communicate fully with Senior Leaders, Peers, Support Partners etc. with matters that are appropriate.
Ability to lead cross-functional teams working on major quality initiatives.
Self-starter with ability to work with minimum supervision and in remote teams.
Travel up to 25% of the work time domestic and international.

BASIC QUALIFICATIONS:

A Bachelors degree in Science, Engineering, or related technical degree.
7+ years of experience in a Quality role in a medical device, pharmaceutical, cosmetic or similar environment.
A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer / Auditor or CQI Chartered Quality Management Professional.
Subject matter expertise in validation in the medical device or pharmaceutical industries.
Project management experience within a complex, matrix or multi-business organization.
Working knowledge and experience with IT infrastructure and computerized systems requiring compliance with various regulatory or other technical requirements.
Proven ability to effectively communicate in written and spoken English.

PREFERRED QUALIFICATIONS:

A minimum of 5 years developing and deploying, efficient and effective quality management systems and management processes, preferably across multiple geographic regions.
Experience in an organization with Quality as a compliance function.
Demonstrated understanding of Medical Devices, Consumer Products, and Cosmetic regulations across the globe. Thorough understanding and experience interfacing with regulatory bodies across all regions.
Understands and can apply industry-standard practices such as Good Manufacturing / Warehouse Practices (GMP & GWP) and Good Validation Practices (GVP).
Knowledge of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for integration considerations into business specific quality strategies.
Understanding of key regulations and standards applicable to K-C specifically related to medical devices as a consumer product.
Is able to influence and engage at varying levels of the organization.
Ability to anticipate and meet deadlines, handling multiple simultaneous deadlines, prioritizing work, strong attention to detail, and the ability to retain confidential information.
Collaborative, responsive, action-oriented and innovative problem solver.
Ability to work and communicate in multiple languages is preferred.
General knowledge and experience of Quality Management application within other functions such as R&E, Procurement, and Distribution is an advantage.
Knowledge of applicable internal and external quality standards and regulations for K-C facilities and products.
Knowledge and experience using CI tools such as A3 strategy development, problem solving, and visual management.

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.

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 position may require a post-offer/pre-hire Physical Abilities Test (PAT) to confirm that individuals are able to perform the essential functions of the job.

K-C requires that an employee have authorization to work in the country in which the role is based. In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization. However, based on immigration requirements, not all roles are suitable for sponsorship. This position is subject to drug and alcohol testing, including pre-employment testing.

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Global VISA and Relocation Specifications:

K-C will support in-country relocation for the chosen candidate for the role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-Cs applicable mobility policies. The benefits/policy provided will decided in K-Cs sole discretion.

This position is subject to drug and alcohol testing, including pre-employment testing.