Director of Quality Management System(QMS) Processes

Director of Quality Management System(QMS) Processes

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Head of Proactive Reg Comp and Standards

Locatie:

North America, United States, New Jersey, Summit

Werklocatie:

Hybride

Wat je gaat doen

Remote work options may be considered on a case-by-case basis and if approved by the Company.

The Director of QMS Processes is responsible for the implementation and oversight of processes defined within the Kenvue Quality Management System (QMS) and Leadership of the Quality Global Process Owners (GPOs) in alignment with Kenvue’s Global Process Ownership model.  This individual is responsible for ensuring GPOs are in place for all key Quality-managed processes, ensuring simplification and driving functional process standardization on a global scale, and also for ensuring compliance to global regulations and Kenvue OKRs.  In addition, this role will coordinate with other key functional GPO Leaders in areas such as Global and Regional Make, Global Smart Operations, Kenvue Operational Excellence, Technical Operations, and Strategic Network Management.  The Director of QMS Processes will be responsible for establishing a collaborative community of practice comprised of these E2E Global Process Owners. This role ensures a high-performing team, with a change mindset. 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. Collaboration with regional teams is required.

For the Quality processes, this individual is responsible for:

• Ensuring all global processes within Kenvue’s E2E GxP QMS are maintained in a state of compliance to global regulations

• Execute the Kenvue Quality System Standards strategy and implement the quality policy and standard documentation hierarchy

• Providing primary leadership for all Quality GPOs and direct management of GPOs dedicated to key Quality Process such as Investigation/CAPA, Change Control, GxP Document Management & Retention, and others as defined by business need by Quality Leadership

• These GPOs will have clearly defined responsibilities, business partners defined, and measures of success that support Kenvue OKRs

• Closely collaborates with the regional Quality Systems leaders to ensure the consistent execution of the QMS across the regions through engagement with regional teams and leaders

• Represent Quality in Kenvue E2E Teams responsible for GPOs and ensuring alignment of the Quality organization to the overall process ownership model being implemented and sustained in Kenvue

• Collaborate with digital transformation office and Quality’s digital team to ensure an ecosystem of technologies are in planned and in place, to support execution of QMS

This role will govern key global processes for Kenvue by leading and facilitating a community of practice for functional GPOs (g a Global Process Ownership (GPO) model, which identifies clear responsibility for key processes defined within the QMS. 

This Team is tasked to:

• Ensuring collective ownership, monitoring progress and updates on overall health to senior management within Quality and Kenvue Supply Chain

• Ensure that all supporting tools and IT solutions meet the needs of the QMS

• Ongoing monitoring of performance measures and ownership of structural risk identification, mitigation, and escalation as needed

• Identify opportunities for improvement to the QMS.

What we are looking for

Required Qualifications

• A minimum of a bachelor’s degree in biology, chemistry, life sciences, engineering, or related field.  Master’s or other advanced degree is preferred.

• A minimum of 10 years in pharmaceutical, medical device, cosmetics or similarly regulated field is required.

• Excellent communication and interpersonal skills to influence leaders across the organization

• Ability to rapidly synthesize information to make decisions

• Proven facilitation skills to bring together cross-functional and global groups to make decisions and come to agreement is critical

• Fluent English is required

• Advanced computer skills, including data analysis, knowledge of ERP and compliance systems, understanding how different tools and systems can work together to achieve the digitization of the QMS

• People Management experience required

• Ability to travel up to 20%

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what's in it for you

$190,825.00 - $269,400.00

Hierbij wordt rekening gehouden met een aantal factoren, waaronder de werklocatie, de vaardigheden, ervaring, opleidingsniveau van de kandidaat & andere werkgerelateerde factoren.

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