Hiring: Director, Quality Assurance Operations Company: BioSpace Location: Redwood City, CA Job Posted Time: 2026-09-02 18:07:01 Employment Type: On-site Target Skills & Keywords : Chai, Compliance, PATs, TestNG About the job Required Skills: •Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of •phase I/II/III investigational product, and compliance to 21 CFR Parts 210, 211, ICH Guidelines •and EU GMPs as applicable. •Accountable for lot disposition activities including batch record review, in-process/release and •stability testing review, oversight of quality events relating to GMP product, process, or facility, •etc. Will lead by example to partner with cross functional groups to meet company objectives in •compliance with applicable regulatory guidelines. •Review approval of development activities in preparation for GMP such as development •studies/reports, engineering activities, etc. •Collaborates with cross functional teams and champions the Quality Risk Management Program. •Responsible for the phase appropriate validation program. •Serves as team leader in quality related discussions, investigations, risk assessments, change •controls, etc. to resolve potential product quality issues and to ensure they are appropriately •addressed and justified. •Partners with Facilities and functional SMEs to support equipment qualifications and lifecycle Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!