Computer System Validation and Laboratory Compliance Lead NA

Computer System Validation and Laboratory Compliance LeadNA

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.

Rollenberichte an:

Senior Director Auditing

Ort:

North America, United States, Pennsylvania, Fort Washington

Arbeitsort:

Vollständig remote

Was Sie tun werden

Responsible for:

• Establishing and executing the regulatory compliance strategy and operational excellence for Technology Services and Technology Quality and Compliance.

• Supporting the execution of the corporate’s Regulatory Compliance audit program serving as a CSV (computer system validation) and Laboratory SME, across Internal Manufacturing (IM), External Manufacturing (EM), suppliers and others to assure audit readiness and compliance with applicable government regulations, company standards, policies, quality agreements, international standards and procedures.

• Identifying, accurately capturing holistic view of potential compliance risks, documenting audit findings and promptly communicating, and as appropriate escalating issues to senior management.

• Issuing and distributing, in a timely manner, audit results for review by management and

• Developing and maintaining effective and collaborative business relationship with key stakeholders and functional department within Kenvue to ensure that the strategic objectives of the corporate audit program are achieved and continuously improving execution and results based on process insights.

• Support execution of supplier audits managed by Technology and Compliance.

• Performing Assessment of CSV and Laboratories as part of execution of the Quality Maturity Model.

• Providing subject matter expertise to Technology groups, global laboratories and other business partners. • Developing compliance strategies that meet regulatory requirements, while enabling innovation.

• Identification of Risk themes resulting from audit observation analysis performed by Regulatory Compliance or Technical Quality & Compliance.

• Partnering with Technology Services, Technical Quality & Compliance, Digital Strategy Quality and NCNH business Units to ensure that NCHC quality standards and global regulatory requirements are met. Ensure integration of new or changing regulations into appropriate QMS and operational processes.

• Owning and continuously improving technology compliance programs within NCHC

• Regulatory Compliance Focus
o Provides support to the year’s audit schedule including pre-audit planning, resourcing, 
scheduling and execution of audits (in-person, remote or using appropriate auditing tools) to 
ensure the audit program is consistently meeting the objectives of achieving a healthy state of 
audit readiness.
o Plans audits to fit auditee’s site type, products, technology and potential linkages to other sites.
o Leads and executes audits, per said schedule or at the discretion of management based on risk or 
prioritization deemed necessary and reports via verbal and written communication any 
outcomes that are in the scope of the audit.
o Immediately escalates significant compliance issues to management capturing description of 
potential violation, severity and potential impact on the company’s products, systems, processes
or consumers.
o Continuously improves technical and interpersonal skills, through training or otherwise, to serve 
as subject matter expert on Regulatory Compliance matters and help stakeholders improve 
awareness of potential gaps and opportunities for remediation.
o While in audit, represents the audit team as an engaged partner fostering trust and collaboration 
to identify strengths and weaknesses, helping the auditee understand their state of compliance 
and allowing the process to provide the appropriate steps to remediate.
o Prepares metrics and performance data as appropriate, based to support identification of 
emerging compliance trends. This will enable providing holistic view of potential compliance 
risks across the company and help deploy countermeasures strategies to prevent impact and 
sustain state of compliance.
o Supports the department effort to maintain the yearly budget.
o Continuously evaluates Regulatory Compliance procedures identifying improvements based on 
input from the changing Regulatory requirements, emerging trends, voice of customer and audit 
outcomes, changes to product, technology portfolios of the company, etc

Was haben Sie davon

$152,150.00 - $214,800.00

Dies berücksichtigt eine Reihe von Faktoren, darunter den Arbeitsort, die Fähigkeiten des Kandidaten, die Erfahrung, das Bildungsniveau und die andere berufsbezogene Faktoren.

Kenvue ist stolz darauf, ein Arbeitgeber für Chancengleichheit zu sein. Alle qualifizierten Bewerber werden unabhängig von Rasse, Hautfarbe, Religion, Geschlecht, sexueller Orientierung, Geschlechtsidentität, Alter, nationaler Herkunft oder geschütztem Veteranenstatus für eine Beschäftigung in Betracht gezogen und nicht aufgrund von Behinderung diskriminiert.