Computer System Validation Lead - NA

Kenvueは現在、a:

Computer System Validation Lead - NA

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Leader Tech Quality and Compliance

North America, United States, New Jersey, Summit

ハイブリッド

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).

• 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.

• 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…