Director of Quality Systems
- Employer
- Scientific Search
- Location
- Emerald Hills, CA
- Closing date
- Dec 8, 2021
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Director, Quality SystemsLocation-Near San Francisco, CACheck out www.scientificsearch.com for all of our openingsOverviewWe are seeking a highly motivated individual to join us as a Director, Quality Systems. In this role, you will manage various aspects Quality Systems, ensure compliance with the quality system's procedures and identify and assess quality risks in activities and processes according to regulatory agency guidelines and quality practices.
Responsibilities
Qualifications
Responsibilities
- Develop operate and maintain the effectiveness of the Quality Management System (QMS) including but not limited to
- Document Control
- Deviations
- Change Control
- CAPA
Qualifications
- BA/BS or MA/MS
- > 10 years QS experience in the biopharmaceutical/biotechnology industry
- Prior experience with Quality oversight of contract organizations
- Strong experience in establishing and maintaining a QMS
- Strong Knowledge of FDA guidelines and regulations regarding cGMPs.
- Strong knowledge and demonstrated practice of ICH Guidelines.
- Excellent interpersonal and communication skills.
- Ability to work in a fast-paced, dynamic environment.
- Strong computer skills, including all MS Office applications.
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