Manager, Pharmaceutical Repackaging Stability Program

Quality Assurance Manager

Quality Assurance contributes to Cardinal Health by developing and implementing quality policies, procedures, and processes to ensure compliance with regulatory standards and specifications. This role oversees the stability program for repackaged pharmaceutical products, ensuring compliance with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines. It demands a strong understanding of stability testing methodologies, quality control principles, data analysis, and a proven track record in a GMP environment.

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. + 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. + 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. + 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. + Cross-Functional Collaboration : Collaborate with project managers, Inventory Management, Sourcing, and other Quality Assurance team members to ensure seamless execution of stability studies and related activities. + Communication : Effectively communicate with internal and external stakeholders, providing updates on stability study progress, addressing technical issues, and ensuring alignment with project timelines and cGMP requirements. + GMP Compliance : Ensure all stability activities are performed in compliance with cGMP regulations, company policies, and industry standards. + Participate in internal and external audits, and implement corrective actions as necessary.

Qualifications

What is expected of you and others at this level

Anticipated salary range : $105,500 - $145,700 Bonus eligible : Yes Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with myFlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs

Application window anticipated to close : 11 / 30 / 2025