Senior Manager, QA Lab Controls and Stability Global Process Owner

Senior Manger, QA Lab Controls and Stability Global Process Owner

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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:

Quality Labs Global Process Owner

Location:

North America, United States, Pennsylvania, Fort Washington

勤務地:

ハイブリッド

あなたがすること

The Senior Manager, QA Laboratory Controls and Stability Global Process Owner (GPO) is the key global contact for the requirements and processes related to laboratory controls and stability within Kenvue’s Global network of Quality Control (QC) Laboratories. This individual is responsible for the development, maintenance and continual improvement of laboratory documentation and stability programs, including defining QC Lab control requirements, overseeing SOP development and governance, and owning standards for data integrity and stability testing across the Kenvue network.

Key Responsibilities

• Develop, deploy and maintain a comprehensive Kenvue Laboratory Controls and Stability Lifecycle Management program, outlining global standards for documentation, data integrity, stability testing, and retirement phases to ensure consistency, efficiency, and compliance with regulatory requirements.

• Collaborate with laboratory personnel, quality assurance teams, and regulatory affairs to ensure seamless integration of controls and stability practices across the organization.

• Provide training and support to laboratory staff on documentation best practices, stability protocols, and lifecycle management processes to enhance operational effectiveness.

• Own the Laboratory Controls and Stability SOP governance process, ensuring alignment with global standards, industry best practices, and regulatory expectations.

• Conduct regular risk assessments of laboratory control systems and stability programs, and collaborate with Site Quality teams to drive risk mitigation strategies throughout the Kenvue network.

• Develop and implement Key Performance Indicators (KPIs) to monitor the quality of documentation, stability program performance, and identify key areas of risk or opportunity. Report findings to senior management for informed decision-making and strategic planning.

• Initiate and lead efforts for continuous improvement of laboratory controls and stability processes, incorporating feedback and industry advancements to optimize performance and compliance.

• Collaborate with regional and cross-functional partners to drive change management activities related to the process, and foster a change mindset to balance a rapid pace of implementing transformational change with the requirements to ensure compliance across all countries where Kenvue operates.

What we are looking for

Required Qualifications

• Bachelor’s degree in chemistry, life sciences, engineering or related field.

• Minimum 10 years in pharmaceutical, medical device, cosmetics or similarly regulated field is required.

• Significant experience in Quality Control Laboratories (Analytical, Micro, or Stability).

• Experience in laboratory documentation, data integrity, and stability program management.

• Fluency in English.

• Strong communication and interpersonal skills to collaborate with regional/local/cross-functional partners.

• Experience in cross-functional, matrixed, and global leadership roles.

• Experience in transformation or significant change management.

• Strong knowledge of Quality Control principles (GxP, ISO ect) and best practices

Desired Qualifications

• Project Management skills.

• Ability to manage change effectively and lead teams through transitions in processes or systems.

• Sensitivity to cultural differences when implementing global processes across various regions.

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それは何ですか

$153,850.00 - $217,200.00

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.

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