Title:                                   Director or Sr. Director, Head of Commercial Quality Control
Reports To:                        Head of Quality ControlLocation:                            Redwood City, California
Classification:                   Exempt 
 
Overview:   

The  Head of Commercial Quality Control will be responsible for all Quality Control procedures and systems for Coherus’ commercial manufacturing and testing CMO network.  Primary responsibilities include oversight of commercial testing, test demand/capacity, and testing cycle time reductions.  The incumbent would be the single point of Contact for the Company with the commercial testing network and will be responsible for the generation, review and compilation of Quality Control required reports, manuals and SOP’s; development and maintenance of Quality Agreements with key commercial contract testing labs.  The incumbent must have hands on experience in the development, establishment, management, and defense of commercial Quality Control systems. Superb quality documentation generation skills and proven communication skills, as well as significant experience in the biopharmaceutical industry, are critical.  

Responsibilities: 

Represent Quality Control on internal project teams and represent Coherus Quality Control to Contract Laboratory Quality counterparts. Develop and review product Certificate of Analysis, Test methods and assay history records. Assist in audits as needed and represent Coherus during regulatory inspections of contract laboratories.  Independently manage method transfer process effectively to deliver analytical methods for protein therapeutics from one site to another.  Coordinate validation and testing activities for release, stability and in-process methods to support the manufacture of protein therapeutic product suitable for FDA and other regulatory agency licensure.    

Specific duties:

• 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.

Qualifications:

• 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.