Job Details

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.
• Repackaged Product Stability: Manage the stability program for all repackaged products.
• Documentation: Develop, review, and approve stability protocols and other relevant documentation.
• Contract Laboratory Management: Manage third-party laboratories executing stability protocols.
• Stability Sample Management: Oversee the shipment of stability samples and ensure appropriate documentation.
• Data Analysis and Trending: Perform stability data trending analysis and compile comprehensive reports.
• Container-Closure Selection: Oversee the selection and qualification of appropriate container-closure systems.
• OOS/OOT Investigations: Lead and conduct Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations.
• Method Transfer/Verification: Responsible for method transfer and 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:

• Bachelor's degree in a relevant scientific field preferred.
• Minimum 8 years of experience in a GMP-regulated pharmaceutical quality oversight environment.
• In-depth knowledge of FDA regulations, ICH guidelines, USP monographs, and other relevant regulatory requirements.
• Proficiency with Laboratory Information Management Systems (LIMS), electronic quality systems, statistical software, and other relevant software applications.
• Demonstrated expertise in conducting OOS/OOT investigations.
• Experience with method transfer and method verification processes.
• Strong problem-solving, analytical, and critical thinking skills.
• Excellent attention to detail, organizational skills, and the ability to manage multiple projects simultaneously.
• Exceptional written and verbal communication skills.

What is expected of you and others at this level includes:

• Managing department operations and supervising professional employees.
• Participating in the development of policies and procedures.
• Ensuring employees operate within guidelines.
• Interacting with subordinates, peers, customers, and suppliers at various management levels.

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. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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.