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
- Repackaged Product Stability
- Documentation
- Contract Laboratory Management
- Stability Sample Management
- Data Analysis and Trending
- Container-Closure Selection
- OOS / OOT Investigations
- Method Transfer / Verification
- Budget Management
- Risk Management
- Team Leadership
- Cross-Functional Collaboration
- Communication
- GMP Compliance
Qualifications include :
Bachelor's degree in a relevant scientific field preferredMinimum 8 years of experience in a GMP-regulated pharmaceutical quality oversight environmentIn-depth knowledge of FDA regulations, ICH guidelines, USP monographs, and other relevant regulatory requirementsProficiency with Laboratory Information Management Systems (LIMS), electronic quality systems, statistical software and other relevant software applicationsDemonstrated expertise in conducting OOS / OOT investigationsExperience with method transfer and method verification processesStrong problem-solving, analytical, and critical thinking skillsExcellent attention to detail, organizational skills, and the ability to manage multiple projects simultaneouslyExceptional written and verbal communication skillsAbility to onboard and engage with external customers and vendorsThorough understanding of cGMP principles and practicesWhat is expected of you and others at this level includes :
Managing department operations and supervising professional employeesParticipating in the development of policies and proceduresEnsuring employees operate within guidelinesInteracting with subordinates, peers, customers, and suppliers at various management levelsAnticipated 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 with myFlexPay, flexible spending accounts (FSAs), short- and long-term disability coverage, work-life resources, paid parental leave, and healthy lifestyle programs.