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, providing updates on stability study progress.
• 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 include medical, dental and vision coverage, paid time off plan, health savings account (HSA), 401k savings plan, access to wages before pay day, flexible spending accounts, short- and long-term disability coverage, work-life resources, paid parental leave, and healthy lifestyle programs.

Application window anticipated to close : 11 / 30 / 2025. If interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including geographical location, relevant education, experience and skills, and an evaluation of internal pay equity. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. Cardinal Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity / expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.