Hiring: Senior Director, Quality Assurance Company: insitro Location: South San Francisco, CA Job Posted Time: 2026-09-03 10:27:05 Employment Type: Hybrid Target Skills & Keywords : GCP, R, Vault About the job Experience: •12+ years in pharma or biotech quality, with progression into senior QA leadership. Required Skills: •Based in South San Francisco, this position reports directly to the Chief Technology Operations Officer and offers an in-person hybrid schedule of either three days per week or one full week per month. •Quality Management System •Own the Operating System: Lead the evolution of insitro's QMS beyond initial setup into an active, effective system •Build and Scale Core Processes: Mature CAPA, deviations, change control, training, and document management to support organizational growth •Author the Standards: Write, revise, and implement SOPs, policies, and quality workflows as the business requires •Qualify and Audit Partners: Own qualification, audits, and quality agreements across CDMOs, CROs, and investigator sites •Facilitate GMP Release: Provide hands-on oversight of product release, batch record review, stability programs, and annual product reviews through Phase 2 in partnership with CMC •Own Clinical Quality: Lead TMF quality, clinical audit planning, and sponsor oversight activities in partnership with clinical operations and data management Qualifications: •Proven Tenure: 12+ years in pharma or biotech quality, with progression into senior QA leadership. •Small-Company Track Record: You have advanced a molecule from preclinical development through IND and into Phase 2 or beyond in a resource-constrained environment with substantial outsourced execution. •GXP Bridge: Deep expertise in either GMP or GCP with genuine working competence in the other. •Systems Builder: Hands-on experience configuring or materially building a QMS such as ZenQMS, Veeva Vault QMS, Qualio, MasterControl, or TrackWise. •Data Integrity Command: Strong grounding in data integrity and computer system validation fundamentals, including ALCOA+, 21 CFR Part 11, GAMP 5 categorization, and audit trail review. •Inspection Experience: You have participated in sponsor-side FDA GMP or BIMO inspection. •Emerging Regulatory Awareness: You follow how regulators are approaching AI/ML in regulated environments and can reason about where the expectations are heading. •Applied Context: You are familiar how AI/ML can be applied to informed discovery, biomarker selection, dose selection, or trial design. •Translation Over Expertise: You can be the quality voice in a room of ML engineers/data scientists without needing to be an ML expert yourself. •Risk-Based and Pragmatic: You build fit-for-stage processes with the judgment to know when something is over-engineered. Compensation: •$273,000 - $290,000 / year 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!