Senior Quality Assurance Manager, R&D Inspection Management

2 weeks ago


Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full time

Job Description


Gilead Sciences is seeking a highly experienced Senior Quality Assurance Manager to lead our R&D Inspection Management team.


As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our R&D inspection management processes.


You will lead the development and maintenance of a comprehensive framework for continually improving inspection management, supporting R&D personnel with readiness, preparation, conduct, and follow-up for GCP, GLP/GCLP, and GPV inspections.


Key responsibilities will include:



  1. Leading the R&D Inspection Management team to ensure compliance with regulatory requirements and Gilead's Quality Management System (QMS)
  2. Developing and implementing strategies to improve inspection readiness and compliance
  3. Collaborating with cross-functional teams to ensure ongoing regulatory compliance and R&D GxP quality operations
  4. Representing Gilead in regulatory inspections and interacting with regulatory agencies

Requirements:



  • BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry
  • Significant experience in inspection management, quality assurance, and compliance in the biopharma industry
  • Proven track record of effective people leadership and management
  • Strong knowledge of GxP requirements, QMS operations, and regulatory compliance


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