Computer System Validation and Laboratory Compliance Lead NA

Computer System Validation and Laboratory Compliance LeadNA

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:

Senior Director Auditing

Locatie:

North America, United States, Pennsylvania, Fort Washington

Werklocatie:

Volledig op afstand

Wat je gaat doen

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

what's in it for you

$152,150.00 - $214,800.00

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

Kenvue is er trots op een werkgever te zijn die gelijke kansen biedt. Alle gekwalificeerde sollicitanten komen in aanmerking voor een baan op basis van verdienste, ongeacht ras, huidskleur, religie, geslacht, seksuele geaardheid, genderidentiteit, leeftijd, nationale afkomst of beschermde veteranenstatus en worden niet gediscrimineerd op basis van handicap.