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Technical Manager for Quality Assurance

2 months ago

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

Overview

TalentBurst is a leader in the development of innovative therapies aimed at addressing serious and life-threatening rare genetic disorders. Our mission is to target conditions that currently lack effective treatment options, impacting small patient populations, including children. We are committed to advancing therapies that represent significant improvements in patient care.

Role Summary
The Technical Manager for Quality Systems plays a crucial role in overseeing the administration and adherence to our Quality Systems, which encompass Documentation, Deviation Management, CAPA, Change Control, Self-Inspection, and Risk Management.

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

Experience:
  • Minimum of 6 years of experience in the pharmaceutical or a related sector.
  • Proven understanding of cGMPs, Health Authority Regulations, Quality Systems, and technical knowledge of manufacturing processes.
  • Ability to interpret technical information related to analytical methods, manufacturing processes, and regulatory standards.
  • Familiarity with FDA, European, and international regulatory guidelines.