Title: Quality System Manager
Location: Novato, CA
Duration: 12 Months on W2
Summary Description
The Quality Systems Technical Manager is responsible for ensuring ***’s Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Self-Inspection and Risk Management are consistently administered and followed.
Responsibilities:
- Participate in inspection readiness, regulatory inspection support and self- inspection activities.
- Quality system metrics and trending.
- Works cross functionally with management within and outside Technical Operations to ensure consistency of use of the quality systems.
- Participate in quality system improvement and process mapping initiatives.
- Author and own site Quality Technical Agreements.
Education:
- BS/MS preferably in the life sciences
Experience:
- 6+ years’ experience in pharmaceutical or related industry.
- Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in manufacturing processes.
- Ability to comprehend technical information related to analytical methods, manufacturing processes and regulatory expectations.
