Senior QA Associate

NGM Biopharmaceuticals, Inc. is a private biotech company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases.  Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to form a company where innovation and cutting edge science has provided the foundation for a robust drug discovery engine.  To date, NGM Bio has generated a pipeline of seven drug candidates in various stages of development, including NGM282 that recently demonstrated proof-of-concept in a Phase 2 study in non-alcoholic steatohepatitis (NASH).  In 2015, we entered into a broad, strategic collaboration with Merck that will provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.

The candidate will be responsible for quality operations to ensure timely review and resolution of quality related matters (i.e. CMO change controls and deviations), batch record review, and product disposition.  Responsible for working closely with CMC to establish GMP documents to support clinical studies. 

Responsibilities:

• Responsible for review and resolution of quality related issues with cross-functional departments and CMOs on master and executed batch production records
• Responsible for preparing lot packet disposition documentation per company procedures
• Responsible for review and approval of analytical validation protocols / reports
• Responsible for review and approval of stability documents
• Coordinate with CMO on quality deviations / investigations resolution and assure implementation of appropriate CAPAs
• Process internal document change requests and maintenance of the document control system
• Responsible publishing newly released documents / revisions
• Update employee training files
• Update and organize QA files
• Perform other duties as assigned

Required Skills:

• Minimum 5 – 7 years QA experience in pharmaceutical or biotech
• Prior experience working with CMOs
• Prior experience with document change control, maintenance of the document change control
• Knowledge in International and FDA regulations
• Strong understanding of cGMPs
• Demonstrate ability to work effectively in a team based environment
• Must be detail-oriented with well-developed organizational and analytical skills
• BS in Science degree

Note: Must be able to work in a fast-paced environment.

NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.

Interested applicants should click "Apply"