Director/Senior Director
Head of Commercial Quality Control
Posted on 12/17/2022
San Carlos, CA, USA
Experience Level
  • Bachelor Degree in Engineering, Chemical or Life Sciences. Advanced degree preferred
  • A minimum of 8-10 years' hands on experience in a Quality organization within the biotechnology industry is preferred, which shall include 5 years' hands on experience in managing Quality groups (both internal and external)
  • Expert knowledge of global cGMP expectations, ICH Quality requirements, and USP/EP/JP
  • Complete understanding of the commercialization of protein-based therapeutic products in the US, and preferably, Europe, Japan, and the non-ICH geographies
  • Excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrix environment
  • A hands-on, “roll up the sleeves” professional willing to try innovative things, have a driving sense of urgency and an experienced “make it happen” orientation within a Program-based, matrix work environment
  • Expert analytical method development experience highly desired
  • Ability to travel both domestically and internationally, up to 25%
  • Demonstrated ability to write reports, presentations, and business correspondence and to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
  • Experience authoring CMC portions of regulatory filings is highly desired
  • Comfortable working in a fast paced and highly expert environment
  • Excellent communication skills and comfortable assuming leadership within teams and with external CMO's
  • Oversee the operations of all commercial Quality Control activities globally for internal and external testing activities
  • Oversee and support method validation and verification activities, and method transfer between sites for commercial products
  • Represent the Quality Control organization in interactions with other key commercial functional units as well as with external contract testing labs
  • Manage QC deviations, CAPAs, and change controls for commercial Coherus products
  • Manage QC inputs to Annual Product Quality Reviews, Quality Management Reviews, Product Quality Reviews
  • Oversee trending of commercial product quality (Drug Substance, Drug Product, Finished Product) and commercial QC analytical method performance
  • Develop or improve Coherus commercial Quality Control standards/process as member of the QC team
  • Conduct GMP audits of commercial CMO's and testing laboratories
  • Serve as Coherus liaison during regulatory inspections of contract labs
  • Lead and /or review laboratory deviation evaluation and resolution activities as required
  • Provide mentorship to direct reports and maintain clear communication on performance to direct reports
  • Travel as required, both domestically and internationally, to ensure compliance to the Company's Quality Management Systems
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.
  • Competitive base salary
  • Target bonus based on performance
  • stock options
  • Medical, dental, & vision coverage
  • PTO
  • 401(k) plan
  • FSA
Company Core Values
  • Performance driven, results oriented to deliver organizational value
  • Team focused
  • Willingness to take risk, responsibility and demonstrate initiative
  • Balanced and thoughtful decision-making