Senior Quality Assurance Manager, R&D Inspection Management
2 weeks ago
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:
- Leading the R&D Inspection Management team to ensure compliance with regulatory requirements and Gilead's Quality Management System (QMS)
- Developing and implementing strategies to improve inspection readiness and compliance
- Collaborating with cross-functional teams to ensure ongoing regulatory compliance and R&D GxP quality operations
- 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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