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Manager, Pharmaceutical Repackaging Stability Program

Manager, Pharmaceutical Repackaging Stability Program

Boston StaffingBoston, MA, US
2 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, 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
  • Ability to onboard and engage with external customers and vendors
  • Thorough understanding of cGMP principles and practices
  • 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 with myFlexPay, flexible spending accounts (FSAs), short- and long-term disability coverage, work-life resources, paid parental leave, and healthy lifestyle programs.

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