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Quality System Manager

San Francisco Metro Area, CA

Posted: 05/22/2019 Job Type: Scientific Job Number: JN -052019-24934
We are currently seeking to hire a motivated Quality Systems Manager who would report to the Senior Director Quality Compliance.

Responsibilities
  • Maintain and monitor quality system processes
  • Ensure Quality Systems conform to GMP and regulatory requirements
  • Lead audit management program
  • Lead supplier audits
  • Write, Review, and approve procedures
  • Develop, track and, communicate quality metrics
  • Manage and Support for Deviation /Change Control, and Document management systems
  • Support GxP training program
  • Provide support and quality assessments of internal and external suppliers to assess compliance risk.

Qualifications
  • Excellent communication skills (interpersonal, written and verbal)
  • Must be well organized, polished, proactive, detail-oriented, mature and have a professional demeanor
  • Ability to multi-task and work efficiently in an environment with changing priorities

Requirements
  • Bachelor of science degree with 3-5 years previous employment in the GMP
  • biotechnology/pharmaceutical Quality Systems field
  • Experience in a start-up environment
  • Strong knowledge of GMP s
  • Thorough knowledge of regulatory requirements as applicable for US and rest of world regions
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