Stability Supervisor 2

Stability Supervisor 2

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：

Sr Manager Quality Plant Support

位置：

North America, United States, Pennsylvania, Fort Washington

工作地点：

完全现场

你会做什么

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

对您有什么好处

$110,500.00 - $156,000.00

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。