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 products and services comply with regulatory standards and specifications. 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.

Responsibilities include :

• 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.
• Documentation : Develop, review, and approve stability protocols for repackaged pharmaceutical products in accordance with regulatory requirements and industry 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 ensure appropriate sample submission documentation.
• Data Analysis and Trending : Perform in-depth stability data trending analysis, identify data anomalies, and compile comprehensive reports.
• Container-Closure Selection : Oversee the selection and qualification of appropriate container-closure systems 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.
• Method Transfer / Verification : Responsible for all method transfer and method verification activities related to stability testing.
• Budget Management : Develop and manage the budget for stability testing activities.
• Risk Management : Conduct risk assessments related to stability and implement appropriate mitigation strategies.
• Team Leadership : Lead, mentor, and develop a team of quality professionals.
• Cross-Functional Collaboration : Collaborate with project managers, Inventory Management, Sourcing, and other Quality Assurance team members.
• Communication : Effectively communicate with internal and external stakeholders.
• GMP Compliance : Ensure all stability activities are performed in compliance with cGMP regulations.

Qualifications include :

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.