Regional Quality Systems Manager - Training, Documentation & Record Management - 2407025603W

Description

Kenvue is currently recruiting for:

Regional Quality Systems Manager - Training, Documentation & Record Management

This position reports into EMEA Quality Systems & Regulatory Intelligence Lead and is based in Prague.

Who we are:

At Kenvue (https://www.kenvue.com/) , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSONS and BAND-AID that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage and have brilliant opportunities waiting for you! Join us in shaping our futureand yours. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M) .

What you will do:

• You will be responsible for supporting the end-to-end oversight and effectiveness of the global Documentation, Training and Quality Record Management, for the EMEA region and to drive standardization, build capability and promote simplification through innovation.

• Together with the Regional Quality Systems & Regulatory Intelligence Lead, manage the implementation and administration of the related global quality management systems for the EMEA region, and ensuring effective communication, collaboration and training are deployed throughout the business.

Key Responsibilities

• Be the regional lead and SME for Training, Documentation and Record Management processes and provide associated training and support across the region.

• Represent EMEA region for related quality system processes at the global level and participate in related global Projects and community of practices.

• Global Procedure Specialist (GPS) role for EMEA region, to oversee, review and approve all EMEA regional SOPs.

• Maintain the Regional Quality System framework in line with the Global Quality Manual and associated forms.

• Regional point of contact

• Support Regulatory Inspection preparedness and management and provide remote Quality Systems support for Regulatory inspections at sites within the region.

• Propose, identify, communicate and deploy processes and related applications, in the region.

• Ensure compliance with global regulatory standards and new or changing regulations.

• Identify and mitigate potential risks in quality system processes

• Lead the implementation of processes, procedures, audits, and corrective actions to improve the related quality management systems in accordance with applicable standards.

• Ensure effective delegation of tasks and projects, reviewing progress reports, and suggesting resource allocation as necessary.

• Support the development and sustainment of the department budget, by ensuring adequate communication of quality compliance needs and efficiencies.

• Evaluate reports on system effectiveness and recommend corrective actions, approving next steps and requesting follow-up reports after implementation.

• Communicate business needs regarding procedures and processes for recording, evaluating, and reporting on quality and reliability.

• Examine results from management reviews, third party inspections, and internal audits and approve proposed corrective actions.

• Prepare and present reports to senior management and other stakeholders on the quality systems performance and compliance.

• To be the regional point of contact for:

• Global Quality Systems Training, Documentation and Record Management

• EMEA Make Quality, Franchise Quality and CQ Quality teams

• TRU & Compliance Wire digital platforms

Qualifications

What we are looking for:

Required Qualifications

• Minimum of 5 years of related experience in global quality management systems and compliance.

• University/Bachelor's Degree or equivalent in a related field.

• Strong understanding of regulatory requirements and industry standards.

• Demonstrated experience in developing and implementing processes, procedures, audits, and corrective actions.

• Track record of successful cross functional partnership and experience of highly matrixed organizations

• Track record of resolving compliance issues

• Change management and project management experience (manufacturing / operational)

Desired Qualifications

• Regulatory inspection experience highly desirable

• Experience in evaluating reports on system effectiveness and recommending corrective actions.

• Ability to examine results from management reviews, third party inspections, and internal audits and approve proposed corrective actions.

• Strong leadership and delegation skills, with the ability to review progress reports and suggest resource allocation and process changes as necessary.

• Excellent communication skills, with the ability to effectively communicate quality compliance needs and status to all affected departments.

Whats In It For You:

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time & More!

• Learning & Development Opportunities

• A challenging and interesting job in one of the biggest global healthcare companies

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Czechia-Prague-Walterovo Namesti

Job Function Quality Systems

Req ID: 2407025603W