Manager/Senior Manager
Quality Assurance
Confirmed live in the last 24 hours
Coherus BioSciences

201-500 employees

Biologic platform therapeutics manufacturer
Company Overview
Coherus' mission is to expand patient access to important, cost-effective medicines and deliver significant savings to the U.S. healthcare system. The company has created the leading biologics platform company solely focused on delivering high-quality biosimilar therapeutics that will expand patient access to life-changing medicines in regulated markets worldwide.

Company Stage


Total Funding





Redwood City, California

Growth & Insights

6 month growth


1 year growth


2 year growth

San Carlos, CA, USA
Experience Level
Desired Skills
Quality Assurance (QA)
QA & Testing
  • Bachelor of Science degree or work experience equivalent to a minimum of 5-7 years of experience in a GMP quality (Mfg/QA/QC) environment, experience in drug substance. Drug product and final packaged product a plus
  • Minimum of 3 years of experience working with contract manufacturing organizations and driving process improvements
  • Prior experience in disposition of biopharmaceutical products
  • Strong knowledge of FDA guidelines and regulations regarding cGMPs
  • Strong knowledge and demonstrated practice of ICH Guidelines
  • Exceptional attention to detail
  • Outstanding written, verbal skills and problem solving skills
  • Strong computer skills, including all MS Office applications
  • Effectively interact with multi-disciplinary functional groups
  • Exercise sound and independent judgment and decision making
  • Ability to work in a fast-paced, dynamic environment
  • Up to ~30% travel required for this position, typically campaign based
  • Good knowledge base and direct experience Drug Substance/API production and QA oversight
  • Review and approval of cGMP documentation, such as master batch records, executed production records, certificates of analysis, and any other quality related records, to support the disposition of Coherus products
  • Participate in validation / tech transfer activities
  • Participate in regularly scheduled meetings with CMOs
  • Drive and troubleshoot quality investigations at CMOs to ensure that all critical quality issues are fully investigated with appropriate actions
  • Alert management of product quality operation issues for proper and timely escalation to Product Quality Review Board (PQRB) and Management Review
  • Quality review of documents from CMOs for compliance with Coherus BioSciences policies/procedures and cGMP's
  • Manage CAPA and Change Controls to support release of Coherus products
  • Participate in development and continuous improvement initiatives of QA processes and SOPs
  • Maintain the effectiveness of the Coherus Quality Management System (QMS) including but not limited to
  • Deviations
  • Change Control
  • CAPA
  • Provides audit support of Coherus BioSciences CMOs, as required
  • Contribute to process improvement initiatives across organization and provide support and direction to maintain quality system to recognized standards
  • Partner/team with stakeholders across the organization to address compliance related issues and processes
  • Support Quality Management with other duties, as required