EM Quality Category Leader

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Role riporta a:

Supplier Quality Packaging Director

Ubicazione:

Europe/Middle East/Africa, Switzerland, Zug, Rotkreuz

Luogo di lavoro:

Completamente in loco

Cosa farai

The External Manufacturing (EM) Quality Category Leader

Based in Switzerland, Rotkreuz or New York, Summit

The External Manufacturing (EM) Quality Category Leader is responsible for the quality oversight and coordination of activities related to the EM category.  This individual is accountable for developing and leading the execution of a quality strategy which is orchestrated as a part of the overall category for the lifecycle management of EM (new product development, commercialization, monitoring of performance, product/technical transfer).  As a subject matter expert for the EM category, he/she will engage in strategic initiatives with Procurement, Make and regional Quality teams.

This individual will work with the EM teams in Procurement, Make and Quality to develop a comprehensive set of performance measures, implementing across the network of EM suppliers.  He/she will also ensure strong, standardized processes are in place to scout and assess potential EMs for compliance and reliability.

This individual collaborates closely with the regional teams who have responsibility for managing External Manufacturers from a Quality standpoint, ensuring standardization of approach across Kenvue.  He/she is also responsible for ensuring appropriate and standardized controls are in place to detect and address the most frequently occurring failure modes for quality at EMs.  This role is also accountable to ensure the correct framework of legal agreements (in the form of Quality Agreements or similar) are in place to ensure accountability with EMs.

Close collaboration with the regional Quality Systems teams is required to ensure alignment, and that necessary revisions or change management is standardized and cascaded globally.  This individual is responsible for presenting data and information to the QHS leadership team to demonstrate the QSMS is in a state of control.

Major Duties & Responsibilities

Strategy development for global management of external manufacturers.  Ensure that standardized processes are in place to manage EM lifecycle and executed consistently in the regions.  These processes include the assessment and selection of EM, Quality Agreement templates and frameworks, performance monitoring, reliability interventions, compliance assessment, risk assessment where required, and disengagement when necessary- 60%

Key global partner for Procurement EM category.  Collaborates closely with the global Procurement organization on the standardization of EM assessment, selection, and monitoring to develop a network of external partners to deliver Kenvue objectives.- 20%

Influence and change management.  This role works closely with regional Quality EM teams to drive consistency across the regions and ensure that learnings from one region is applied globally.  The organization must be able to balance a rapid pace of implementing transformational change, with the requirement to ensure compliance across all countries where Kenvue operates. – 20%

Required Qualifications

Minimum of a bachelor’s degree in chemistry, life sciences, engineering, or related field. 

Required Years of Related Experience:      Minimum 8 years in pharmaceutical, medical device, cosmetics or similarly regulated field is required.

Required Knowledge, Skills and Abilitiess

• Strong communication and interpersonal skills to collaborate with regional partners
• Compliance mindset, to ensure systems are correctly executed at a global level
• Fluent English is required
• Knowledge of regulatory requirements for drugs, cosmetics, medical devices, and dietary supplements
• Experience in Health Authority inspections
• Experience in External Manufacturer management

Other Duties:

• Collaboration with the digital team is required to ensure appropriate planning for systems implementation and changes

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