Role reports to:Sr Manager Quality Plant Support
Location:North America, United States, Pennsylvania, Fort Washington
Work Location:Fully Onsite
What you will doThe 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 forRequired 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
What's in it for youAnnual base salary for new hires in this position ranges:
$110,500.00 - $156,000.00
This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.
- Competitive Benefit Package*
- Paid Company Holidays, Paid Vacation, Volunteer Time & More!
- Learning & Development Opportunities
- Kenvuer Impact Networks
- This list could vary based on location/region
*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
