Quality Assurance Technical Manager

2 weeks ago


Novato, California, United States TalentBurst Full time
Position: Technical Manager, Quality Systems

Company Overview
TalentBurst is a leader in providing innovative solutions for patients facing serious and rare genetic conditions. Our mission is to develop effective therapies for diseases that currently have limited treatment options, focusing on improving the lives of those affected, especially children.

Role Overview
The Technical Manager for Quality Systems plays a pivotal role in overseeing the adherence to our Quality Systems, which encompass Documentation, Deviation Management, CAPA, Change Control, Self-Inspection, and Risk Management. This position is crucial for maintaining the integrity and compliance of our operations.

Key Responsibilities:
  • Support inspection readiness and provide assistance during regulatory inspections and self-inspection activities.
  • Analyze quality system metrics and trends to ensure continuous improvement.
  • Collaborate across various departments to promote consistent application of quality systems.
  • Engage in initiatives aimed at enhancing quality systems and process mapping.
  • Draft and manage site-specific Quality Technical Agreements.
Qualifications:
Education:
Bachelor's or Master's degree in a relevant field, preferably in life sciences.

Experience:
  • A minimum of 6 years in the pharmaceutical or a related industry.
  • Proven understanding of cGMPs, regulatory standards, and quality systems.
  • Strong ability to interpret technical information related to analytical methods and manufacturing processes.
  • Knowledge of FDA, European, and international regulatory requirements.


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