Stability Supervisor 2

What You Will Do

• 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.

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.

Pay

Annual 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.

Benefits

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Kenvuer Impact Networks