Computer System Validation and Laboratory Compliance Lead NA

Computer System Validation and Laboratory Compliance LeadNA

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Senior Director Auditing

Posizione:

North America, United States, Pennsylvania, Fort Washington

Luogo di lavoro:

Completamente remoto

Cosa farai

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

Cosa c'è per te

$152,150.00 - $214,800.00

Questo tiene conto di una serie di fattori tra cui il luogo di lavoro, le competenze del candidato, l'esperienza, il livello di istruzione e altri fattori legati al lavoro.

Kenvue è orgogliosa di essere un datore di lavoro per le pari opportunità. Tutti i candidati qualificati saranno presi in considerazione per l'impiego in base al merito, indipendentemente da razza, colore, religione, sesso, orientamento sessuale, identità di genere, età, origine nazionale o stato di veterano protetto e non saranno discriminati sulla base della disabilità.