Manager, Pharmaceutical Repackaging Stability Program

What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Job Summary
This role is responsible for the oversight and management of the stability program for repackaged pharmaceutical products, ensuring compliance with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines. This role demands a strong understanding of stability testing methodologies, quality control principles, data analysis, and a proven track record in a GMP environment. This role helps ensure the quality, safety, and efficacy of products through the development, implementation, and maintenance of robust stability protocols, testing procedures, and quality systems.

The manager will lead cross functional collaborations and possess exceptional communication and interpersonal skills to effectively collaborate with internal business partners and external stakeholders.

Responsibilities

• Program Oversight: Develop, maintain, and oversee the stability program and related studies, ensuring alignment with cGMP requirements and industry best practices.
• Repackaged Product Stability: Manage the stability program for all repackaged products, ensuring appropriate stability studies are designed and executed to support the shelf life and storage conditions of these products. This includes developing specifications, protocols and acceptance criteria for repackaged products.
• Documentation: Develop, review, and approve stability protocols for repackaged pharmaceutical products in accordance with regulatory requirements and industry standards. Generate, review, and revise Standard Operating Procedures (SOPs), protocols, reports, and other relevant documentation to ensure compliance with cGMP and regulatory standards.
• Contract Laboratory Management: Manage third party laboratories executing stability protocols, including oversight of data integrity, adherence to cGMP and performance monitoring.
• Stability Sample Management: Oversee the shipment of stability samples from repackaging facilities to laboratories and ensuring appropriate sample submission documentation.
• Data Analysis and Trending: Perform in-depth stability data trending analysis, identify data anomalies, and compile comprehensive reports, ensuring data integrity and compliance with cGMP. Manage the preparation and review of Annual Product Reviews to identify trends, assess product performance, and ensure continued product quality.
• Container-Closure Selection: Oversee the selection and qualification of appropriate container-closure systems (specifically foil and film for unit dose blisters) to ensure product integrity and stability throughout shelf-life.
• OOS/OOT Investigations: Lead and conduct thorough Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations related to stability data, including root cause analysis, hypothesis testing, and implementation of corrective and preventive actions (CAPAs) to prevent recurrence. Ensure investigations are initiated and completed in a timely manner, adhering to established timelines and regulatory expectations. Ensure investigations are well-documented, scientifically sound, and compliant with cGMP requirements.
  
  Serve as the primary point of contact for escalating quality issues and concerns to the drug manufacturer, ensuring timely resolution and communication.
• Method Transfer/Verification: Responsible for all method transfer and method verification activities related to stability testing, ensuring successful implementation and validation of analytical methods across multiple laboratories. This includes protocol development, data review, and troubleshooting.
• Budget Management: Develop and manage the budget for stability testing activities, ensuring cost-effective utilization of resources.
• Risk Management: Conduct risk assessments related to stability and implement appropriate mitigation strategies.
• Team Leadership: Lead, mentor, and develop a team of quality professionals. Provide clear direction, set performance expectations, and provide regular feedback. Foster a collaborative and high-performing team environment. Effectively delegate tasks and responsibilities to team members, ensuring appropriate workload distribution and skill development opportunities.
• Cross-Functional Collaboration: Collaborate with project managers, Inventory Management, Sourcing, and other Quality Assurance team members to ensure seamless execution of stability studies and…