Manager – Quality Assurance
Posted on 7/19/2023
INACTIVE
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.
Biotechnology

Company Stage

N/A

Total Funding

$1.2B

Founded

2010

Headquarters

Redwood City, California

Growth & Insights
Headcount

6 month growth

0%

1 year growth

-4%

2 year growth

0%
Locations
San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Quality Assurance (QA)
CategoriesNew
QA & Testing
Requirements
  • Bachelor of Science degree or work experience equivalent to a minimum of 5-7 years of QA experience in a GMP (Mfg/QA/QC) biopharmaceutical environment
  • Minimum of 3 years of experience working with contract manufacturing organizations and driving process improvements
  • Prior experience in disposition of biopharmaceutical products. Clincal product disposition preferred
  • 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
Responsibilities
  • Good knowledge base and direct experience of biopharmaceutical manufacturing of intermediates and finished product (i.e., WCB/MCB, drug substance, drug product, final packaged product) and QA oversight
  • Review and approval of cGMP documentation, such as master batch records, executed production records, certificates of analyses, quality systems records, to support the disposition of Coherus clinical products
  • 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 cGMPs
  • Manage CAPA and Change Controls to support release of clinical products
  • Support the final disposition activities of pre-commercial/commercial products
  • Support manufacturing process transfers, as well as, process validation activities for late phase clinical programs
  • Support inspection readiness and commercialization activities to include BLA authoring, date verification and information request support
  • Participate in development 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