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Senior Manager, Quality Assurance and CAPA Oversight

2 months ago

South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full time
R&D Deviation and CAPA Oversight
R&D Quality and Medical Governance
Key Responsibilities

  • Direct and guide investigations into quality events, ensuring timely development of Corrective and Preventive Actions (CAPA) in collaboration with relevant experts.
  • Develop, implement, and enhance educational resources and tools to foster proficiency in quality event management.
  • Monitor the consistency and promptness of deviation and CAPA resolutions.
  • Collaborate with process owners to pinpoint challenges and enhancement opportunities, spearheading initiatives for improvement.
  • Support the quality management system by maintaining comprehensive records of issues and enhancement requests, facilitating the execution of system modifications.
  • Manage notifications to leadership and oversee the escalation process.
  • Engage in risk assessments, serving as a facilitator for risk management activities.
Candidate Qualifications

  • Proficient in GxP environments.
  • Over 10 years of experience in the biopharmaceutical sector.
  • More than 6 years of experience in managing investigations (deviations, CAPA, etc.).
  • Skilled in drafting investigation reports.
  • Demonstrated expertise in Root Cause Analysis (RCA).
Project Management Skills

  • Highly self-motivated individual.