Stability Supervisor 2

Stability Supervisor 2

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Sr Manager Quality Plant Support

Posizione:

North America, United States, Pennsylvania, Fort Washington

Luogo di lavoro:

Completamente in loco

Cosa farai

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

Cosa c'è per te

$110,500.00 - $156,000.00

Questo tiene conto di una serie di fattori tra cui il luogo di lavoro, le competenze del candidato, l'esperienza, il livello di istruzione e altri fattori legati al lavoro.

Kenvue è orgogliosa di essere un datore di lavoro per le pari opportunità. Tutti i candidati qualificati saranno presi in considerazione per l'impiego in base al merito, indipendentemente da razza, colore, religione, sesso, orientamento sessuale, identità di genere, età, origine nazionale o stato di veterano protetto e non saranno discriminati sulla base della disabilità.