Complaint Vigilance Manager

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

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Was Sie tun werden

The Manager of Complaint Vigilance is responsible for the complaint management process and organization in the LATAM region. This role ensures compliant execution of the complaint process. Ensures all quality targets are achieved or exceeded for timely processing. Oversees and approves complaint investigations for procedural adherence, accuracy, and completeness. Review’s metrics and reports to monitor complaint vigilance process for timely execution, identify product trends and promote continuous improvement. Coordinates and prepares as needed the regional complaint reports and presentations to cross-functional leadership and Quality Management. The incumbent will represent Kenvue with Health Authorities and other regulators as needed on the topic of product quality complaints. Collaborates with Consumer Care Center business partners regarding complaint intake process, new product launches and process execution. Partners with the Medical Safety Organization regarding investigation of adverse events.

The Manager of Complaint Vigilance leads the complaint vigilance process in accordance with current standards and procedures. This role participates in the Global CV Change Governance process to ensure continued alignment and consistency of execution. Leads and mentors a staff of professionals executing the complaint vigilance process. Empowers staff and ensures their continued development. Possesses the maturity and proficiency to lead direct reports. Possesses proven influencing capability outside of their organization. Their leadership influence (implementing the vision and governance) must be extended across the region to ensure vigilance operations meet expectations.

• Provides leadership and support in execution of the complaint management process in the regions. Leads all aspects of the complaint process including receipt, evaluation and coordination with internal (and external sites as needed) to investigate and close product quality complaints. Ensures investigations meet procedural requirements and are completed and closed in a timely manner.

• Provides oversight to ensure all quality targets are achieved or exceeded for timely processing and investigation of complaints, notification to management, system surveillance, and trending. Maintains process for system surveillance and timely escalation to management of adverse trends within the product quality complaints system.

• Participates on project teams; supports development, effective process, continued maintenance, and ensures compliance is achieved and standards are met. Represents Complaint Vigilance processes to regulatory agencies upon request and supports regulatory inspections. Ensures audit readiness LATAM Complaint Vigilance and documentation.

• Collaborates with Quality Systems & Performance, Business & Franchise Quality, Consumer Care Center, Office of Consumer Medical Safety, Quality (External and Internal Sites), etc. at Management level to ensure compliant and consistent process execution and documentation.

• Manages and provides leadership and organizational capability development. Ensures succession planning and performance standards remain at an optimal level to maintain compliance.

Provides leadership and support in execution of the complaint management process in the regions. Leads all aspects of the complaint process including receipt, evaluation and coordination with internal (and external sites as needed) to investigate and close product quality complaints. Ensures investigations meet procedural requirements and are completed and closed in a timely manner. 

Provides oversight to ensure all quality targets are achieved or exceeded for timely processing and investigation of complaints, notification to management, system surveillance, and trending. Maintains process for system surveillance and timely escalation to management of adverse trends within the product quality complaints system.

Participates on project teams; supports development, effective process, continued maintenance, and ensures compliance is achieved and standards are met. Represents Complaint Vigilance processes to regulatory agencies upon request and supports regulatory inspections. Ensures audit readiness LATAM Complaint Vigilance and documentation. 

Collaborates with Quality Systems & Performance, Business & Franchise Quality, Consumer Care Center, Office of Consumer Medical Safety, Quality (External and Internal Sites), etc. at Management level to ensure compliant and consistent process execution and documentation.

Manages and provides leadership and organizational capability development. Ensures succession planning and performance standards remain at an optimal level to maintain compliance.

What we are looking for
Bachelor of Science, Engineering or Equivalent Degree in a relevant discipline 
Solid experience leading or managing successful quality and compliance initiatives/projects/departments in a regulated industry.
Expertise in quality processes and regulatory requirements; special focus on Pharmaceutical and/or medical devices
Experience in the creation, update, and management of complaint files from complaint identification through closure 
Experience working in or supporting manufacturing, packaging, and development operations
Experience managing a complaint management team or function, leading matrix teams and managing direct reports 
Excellent written and oral communication and interpersonal relationship skills 
Strong influencing, negotiations, and leading without direct line authority experience is required 
The ability to manage complexity and manage a diverse team is critical 
Demonstrated critical thinking, people and team development, strategic aptitude, independent leadership skills, and ability to interact with Regulatory Authorities 
Strong knowledge of cGMP Regulations and ISO guidelines is required
Advanced / Fluent English is mandatory

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