Director of Quality Management System(QMS) Processes

Director of Quality Management System(QMS) Processes

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

Head of Proactive Reg Comp and Standards

Location :

North America, United States, New Jersey, Summit

Lieu de travail :

Hybride

Ce que tu vas faire

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%

#LI-SR1

Qu'est-ce que vous y gagnez

$190,825.00 - $269,400.00

Cela prend en compte un certain nombre de facteurs, notamment le lieu de travail, les compétences du candidat, son expérience, son niveau d'éducation et autres facteurs liés à l'emploi.

Kenvue est fier d'être un employeur souscrivant au principe de l'égalité d'accès à l'emploi. Tous les candidats qualifiés seront pris en considération pour un emploi basé sur le mérite, sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'âge, l'origine nationale ou le statut d'ancien combattant protégé et ne seront pas discriminés sur la base du handicap.