Technical Manager, Quality Systems
Novato, CA
12 Months
No Corp-to-Corp
Hybrid role - 2-3 days - maybe more as business needs change
Description
Client is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any treatment options. Client will continue to focus on advancing therapies that are the first or best of their kind.
Client's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain Client's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come to join our team and make a meaningful impact on patients’ lives.
Summary Description
The Quality Systems Technical Manager is responsible for ensuring Client'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.
- Familiarity with FDA, European and international regulatory requirements.
