Stability Supervisor 2

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在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

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你會做什麼

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

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