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Manager of Quality Systems Engineering

2 months ago

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

Overview

Join a leading organization dedicated to providing innovative therapeutics for patients with serious and rare genetic conditions. Our mission focuses on developing treatments for diseases that currently have limited or no effective options, particularly for vulnerable populations such as children.

Role Summary
The Quality Systems Technical Manager plays a pivotal role in overseeing the adherence and implementation of Quality Systems, including Documentation, Deviation Management, CAPA, Change Control, Self-Inspection, and Risk Management.

Key Responsibilities:
  • Support preparation for inspections, including regulatory audits and self-assessments.
  • Analyze quality system metrics and identify trends.
  • Collaborate with cross-functional teams to ensure uniform application of quality systems.
  • Engage in initiatives aimed at enhancing quality systems and process mapping.
  • Draft and manage site-specific Quality Technical Agreements.
Qualifications:
Bachelor's or Master's degree, preferably in life sciences.

Experience Requirements:
  • A minimum of 6 years of experience in the pharmaceutical or a related sector.
  • Proven understanding of cGMPs, regulatory standards, and quality systems, along with technical knowledge of manufacturing processes.
  • Ability to interpret technical documentation related to analytical methods and regulatory expectations.
  • Familiarity with FDA, European, and international regulatory frameworks.