Novato, CA
Quality Technical Manager
Quality Systems Technical Manager
Location: Novato, CA
9-month assignment (potential to extend)
Pay Rate: $50-60/hour
Our leading pharmaceutical client is looking for a global leader in developing therapeutics for patients with serious and life-threatening rare genetic diseases.
Summary Description: The Quality Systems Technical Manager plays a vital role in ensuring the consistent and effective administration of Quality Systems. This includes overseeing key areas such as Documentation, Deviation, CAPA, Change Control, Self-Inspection, and Risk Management.
Responsibilities:
- Participate in inspection readiness, regulatory inspection support, and self-inspection activities.
- Monitor quality system metrics and trends to identify areas for improvement.
- Collaborate with internal and external stakeholders to ensure consistent use of quality systems.
- Contribute to quality system improvement and process mapping initiatives.
- Author and oversee site Quality Technical Agreements.
Education:
- Bachelor's or Master's degree in life sciences preferred.
Experience:
- Minimum of 6 years' experience in the pharmaceutical or related industry.
- Demonstrated expertise in cGMPs, Health Authority Regulations, and Quality Systems.
- Strong technical understanding of manufacturing processes and regulatory expectations.
- Familiarity with FDA, European, and international regulatory requirements.