Computer System Validation and Laboratory Compliance Lead NA

Computer System Validation and Laboratory Compliance LeadNA

O que fazemos

At Kenvue, percebemos o extraordinário poder do cuidado diário. Construída com base em mais de um século de herança e enraizada na ciência, somos a casa de marcas icônicas - incluindo NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® que você já conhece e ama. A ciência é a nossa paixão; O cuidado é o nosso talento.

Quem somos

Nossa equipe global é de ~ 22.000 pessoas brilhantes com uma cultura no local de trabalho onde cada voz é importante e cada contribuição é apreciada. Somos apaixonados por insights, inovação e comprometidos em entregar os melhores produtos aos nossos clientes. Com experiência e empatia, ser um Kenvuer significa ter o poder de impactar milhões de pessoas todos os dias. Colocamos as pessoas em primeiro lugar, nos importamos ferozmente, ganhamos confiança com a ciência e resolvemos com coragem - e temos oportunidades brilhantes esperando por você! Junte-se a nós para moldar nosso futuro - e o seu. Para obter mais informações, clique em aqui.

Role reporta para:

Senior Director Auditing

Location:

North America, United States, Pennsylvania, Fort Washington

Local de trabalho:

Totalmente remoto

O que você fará

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

O que você ganha com isso

$152,150.00 - $214,800.00

Isso leva em consideração vários fatores, incluindo local de trabalho, habilidades do candidato, experiência, nível de educação e outros fatores relacionados ao trabalho.

A Kenvue tem orgulho de ser um empregador de oportunidades iguais. Todos os candidatos qualificados serão considerados para o emprego com base no mérito, independentemente de raça, cor, religião, sexo, orientação sexual, identidade de gênero, idade, nacionalidade ou status de veterano protegido e não serão discriminados com base na deficiência.