Computer System Validation and Laboratory Compliance Lead NA

Computer System Validation and Laboratory Compliance LeadNA

私たちがしていること

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.

Who We Are

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.

Role reports to:

Senior Director Auditing

Location:

North America, United States, Pennsylvania, Fort Washington

勤務地:

完全リモート

あなたがすること

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

それは何ですか

$152,150.00 - $214,800.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

Kenvueは機会均等雇用者であることを誇りに思っています。人種、肌の色、宗教、性別、性的指向、性同一性、年齢、出身国、または保護された退役軍人の地位に関係なく、すべての資格のある応募者は、能力に基づいて雇用の検討を受け、障害に基づいて差別されることはありません。