Quality Manager III

Katalyst HealthCares & Life Sciences

📍 Swiftwater, Pennsylvania, United States

Full-time Operations Specialties Managers

Job Description


Job Description:
  • We are seeking a highly skilled Quality Manager III with a strong engineering background to join our Quality Validation team.
  • This role is pivotal in ensuring the integrity of computerized systems and equipment within a high-stakes biopharmaceutical manufacturing environment.
  • The ideal candidate will bridge the gap between technical engineering requirements and rigorous regulatory compliance, specifically focusing on computerized system validation (CSV) and equipment qualification.
  • Key Responsibilities:
  • Lead and execute computerized system validation (CSV) and computerized equipment qualification projects to ensure compliance with global regulatory standards.
  • Direct and manage Corrective and Preventive Action (CAPA) activities, ensuring thorough root cause analysis and timely implementation of effective solutions.
  • Serve as the primary quality interface for engineering and manufacturing te...
  • Apply for this Position