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Manager, Pharmaceutical Repackaging Stability Program

Manager, Pharmaceutical Repackaging Stability Program

Oregon StaffingSalem, OR, US
8 days ago
Job type
  • Full-time
Job description

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 preferred
  • Minimum 8 years of experience in a GMP-regulated pharmaceutical quality oversight environment
  • In-depth knowledge of FDA regulations, ICH guidelines, USP monographs
  • Proficiency with Laboratory Information Management Systems (LIMS), electronic quality systems, statistical software
  • 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
  • Anticipated salary range : $105,500 - $145,700. Bonus eligible : Yes. Benefits include medical, dental and vision coverage, paid time off, health savings account, 401k savings plan, work-life resources, and more. Application window anticipated to close : 11 / 30 / 2025.

    Cardinal Health offers a wide variety of benefits and programs to support health and well-being. 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.

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