Principal Quality Specialist - Global QMS
Location - Reigate
Competitive Salary and Benefits Package
The Quality Management System Specialist brings subject matter expertise and utilizes experience along with best practice knowledge to lead the technical development and implementation of specific areas of the Kimberly-Clark Quality Management System.
Accountable to establish and maintain assigned elements of the standards, procedures, guidance documents and forms which make up the Enterprise-wide Global Quality Management System.
Ensure assigned Global Quality Management System standards and procedures are integrated into systems and processes in Regions, Business Units and other functions as required.
Identify, map and document new Enterprise-wide Quality, Regulatory and Product Safety processes associated with providing products and services which satisfy all customer and other stakeholder needs.
Develop and deploy education and training as required to ensure awareness and usage of assigned Global QMS documents.
Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Takes leadership of the development and deployment of strategic quality management plans, initiatives and measures which generally have significant Enterprise-wide scope and impact.
Develops standardized approaches aligned with industry best practices in quality management, including, but not limited to Corrective and Preventative Actions, Quality Non-Conformances, Management Review, Quality Metrics, Change Management, Training Systems and Document Control and Record Management.
Leads quality system improvement programs enterprise-wide to establish and improve Quality Management System elements to ensure business, facility and corporate objectives are met.
Maintains comprehensive knowledge of applicable regulatory requirements and interpretation.
Provides regulatory compliance expertise by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the enterprise.
GENERAL EXPECTATIONS AND ACCOUNTABILITIES
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 quality management systems, 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 effectively with Senior Leaders, Peers, Functional Partners.
A Bachelor’s degree in Sciences, Engineering, Supply Chain, Operations or equivalent degree.
Extensive experience in a Quality Management 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
Proven ability to communicate in written and spoken English.
Experience developing and deploying, efficient and effective quality management system elements and 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)
Demonstrate understanding and impact 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.
Non-conformance and CAPA ownership/management experience
Training system development and/or management
Experience working in quality systems where these regulations and guidelines are followed: 21 CFR Part 820, 21 CFR Part 11, MDSAP, EU MDR, EU MDD, ISO13485
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
- Competitive basic salary
- Performance related bonus
- Private healthcare
- 25 days holiday plus bank holidays
You can also choose from our flexible benefits package which includes:
- Holiday trading
- Share scheme options
- Critical illness cover
- Travel insurance
- Dental cover
- And many more!
At Kimberly-Clark we are happy to consider requests for flexible working, which can include flexible hours, an element of working from home, compressed hours etc.
If this is something you wish to explore, please highlight at interview stage
Health, safety and wellbeing is of paramount importance here at Kimberly-Clark. Due to the ongoing situation with COVID-19, please therefore note that all interviews are currently only being scheduled via our online video interviewing platforms. This means we can continue to identify and hire great talent in a safe and secure manner.
If you have any questions about this process, please do not hesitate to ask your recruiter.
The Legal Bit!
The statements above are intended to describe the general nature and level of work performed by employees assigned to this role. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, 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.
KC is a sponsor of the Recruitment and Employment Confederation Good Recruitment Campaign