Computer System Validation Lead - NA

Computer System Validation Lead - NA

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

Leader Tech Quality and Compliance

位置：

North America, United States, New Jersey, Summit

工作地点：

混合

你会做什么

Technology Quality and Compliance (TQ&C) manages the quality and compliance strategy for technology systems including applications, infrastructure, and digital health solutions. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with the company’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with addressing compliance gaps related to audits and inspections.

The Lead Computer Systems Validation Specialist (CSV) NA is responsible for the building and execution of quality into enterprise wide systems, tools, services, and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, and retire).

Roles and Responsibilities:

• Engaging with technology team members ensuring early involvement of TQ&C in the design and development of applications and infrastructure, building quality into the work product, and controls within the application/solution while leveraging automation whenever feasible.
• Ensuring company quality standards and regulatory requirements are met for the systems under the scope of responsibility.
• Planning, executing, coordinating, and maintaining the validation activities for the systems within their scope, including approval of SDLC validation documentation, release system implementation, and/or changes for production use while providing computerized systems validation guidance and support to support team members in the execution of system base business activities, enhancements, and small projects.
• Reviewing and approving SOPs and WIs related to the systems within their scope and assisting with incident management/CAPA (Corrective and Preventative Action) and NCs for systems supported.
• Supporting internal audits, Health Authority regulatory inspections, and system periodic reviews.

What we are looking for

Required Qualifications

• Bachelor's degree or equivalent in Business, Marketing, Data Science, or a related field.
• 4 to 6 years of experience in customer success, value management, process validation, equipment qualification, or related quality assurance roles.
• Strong knowledge of industry regulations, validation policies, and quality systems.
• Proven ability to analyze technical problems and implement corrective actions.
• Experience in developing and reviewing validation and qualification documentation.
• Excellent communication skills for effective collaboration with cross-functional teams and external parties.

Desired Qualifications

• Proven expertise in leveraging analytics tools and CRM platforms to drive customer insights and strategic decision-making.
• Exceptional communication skills with the ability to translate complex data into compelling narratives for diverse stakeholders.
• Demonstrated leadership capabilities with a track record of mentoring teams and driving cross-functional collaboration.
• Capability to lead validation activities and represent the function during audits and inspections.
• A proactive mindset with a passion for innovation, continuously seeking novel approaches to enhance customer value and business growth.

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对您有什么好处

$90,100.00 - $127,200.00

这考虑了许多因素，包括工作地点、候选人的技能、经验、教育水平和其他与工作相关的因素

Kenvue 很自豪能成为一个机会均等的雇主。所有合格的申请人都将根据业绩获得就业考虑，不分种族、肤色、宗教、性别、性取向、性别认同、年龄、国籍或受保护的退伍军人身份，并且不会因残疾而受到歧视。