Stability Supervisor 2

Stability Supervisor 2

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:

Sr Manager Quality Plant Support

Location:

North America, United States, Pennsylvania, Fort Washington

勤務地:

フルオンサイト

あなたがすること

The Stability Supervisor 2 is responsible for overseeing quality records, managing corrective and preventive actions, and leading investigations to ensure compliance and continuous improvement. You will coordinate quality projects, review documentation, and support audits to enhance manufacturing processes and risk management:

Key Responsibilities

• Lead and innovate stability protocols by integrating advanced monitoring technologies and predictive analytics models to ensure product integrity and optimize shelf-life predictions throughout the product lifecycle.

• Supervise, mentor, and coordinate a dynamic team of quality specialists, fostering a culture of continuous improvement, proactive problem-solving, and effective execution of quality projects, stability studies, and analytical investigations.

• Collaborate cross-functionally with R&D, Quality Assurance, Manufacturing, and contract manufacturers to streamline stability workflows, ensure compliance, and enhance data accuracy and quality consistency.

• Drive compliance with global regulatory standards by developing forward-thinking stability strategies, managing change control documentation, and leading corrective and preventive action (CAPA) plans with thorough reporting on their closure and effectiveness.

• Analyze stability data and quality system reports to identify trends, recommend improvements, reduce cycle times, and prepare comprehensive quality stability reports contributing to regulatory submission documentation.

• Champion sustainability initiatives by identifying eco-friendly materials and processes that maintain product stability without compromising quality.

• Utilize data visualization tools to present complex stability and quality data insights to stakeholders, facilitating informed decision-making and ensuring readiness for audits and inspections through continuous improvement initiatives.

• Oversee and ensure accurate maintenance of quality records related to product testing, nonconformance, and project outcomes, ensuring timely stakeholder communication and audit readiness.

• Assures the laboratory operates in a compliant manner consistent with cGMP’s and safety standards.

• Reviews and approves laboratory data generated by Analytical Scientists for completeness and accuracy.

• Supervises and facilitates the workload through the Laboratory to best meet company objectives.

• Performs investigations on OOS/OOT results in accordance with company procedures.

• Interacts with various internal departments and external divisions on a routine basis to coordinate stability efforts.

• Provides technical direction, mentoring, and training to Scientists.

• Provides timely performance reviews and feedback to direct reports.

• Assists Laboratory Manager with performance, development, staffing and recruitment needs for the laboratory.

• Identifies and implements opportunities to improve the laboratory compliance profile and laboratory efficiency.

What we are looking for

Required Qualifications

• Bachelor’s degree or equivalent in Pharmaceutical Sciences, Chemistry, or a related scientific or technical discipline.

• 6-8 years of progressive experience in stability supervision, quality supervision, stability analysis, or related fields within a regulated environment.

• Strong knowledge of quality management systems, CAPA processes, and regulatory requirements related to stability and manufacturing quality.

• Excellent communication and interpersonal skills to effectively liaise with multidisciplinary teams and external regulatory bodies.

Desired Qualifications

• Proven ability to leverage emerging technologies such as AI and machine learning to enhance stability testing and data interpretation.

• Exceptional leadership skills with a track record of inspiring teams to exceed performance goals in a regulated environment.

• In-depth knowledge of ICH guidelines, GMP standards, and global regulatory requirements related to product stability.

• Strong analytical mindset with proficiency in statistical software and data management systems relevant to stability studies.

• Demonstrated proficiency in advanced Microsoft Office applications, including expert-level skills in Excel (v-look up, h-look up, macros, pivot tables) and PowerPoint.

• Experience in analyzing syndicated data and generating actionable reports to support quality and compliance decisions.

• Proven ability to lead diverse teams and manage multiple projects simultaneously with effective prioritization and communication skills.

#Li-SR1

それは何ですか

$110,500.00 - $156,000.00

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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