Senior Director, Quality Assurance

The role

You will build and own a pragmatic quality function for clinical-stage operations. This includes standing up the QMS and SOPs, overseeing vendor audits, and managing GMP and GCP quality.

What you will do

• Lead the evolution of the QMS
• Mature CAPA, deviations, change control, training, and document management
• Write, revise, and implement SOPs, policies, and quality workflows
• Qualify and audit partners including CDMOs, CROs, and investigator sites
• Provide oversight of product release, batch record review, stability programs, and annual product reviews
• Lead TMF quality, clinical audit planning, and sponsor oversight activities
• Prepare the organization for pre-IND, IND, and BIMO milestones
• Define expectations for documentation, traceability, review, and change control
• Partner with Compute and Data Science on model documentation and validation
• Contribute quality and data integrity context to partnership and diligence conversations

Required qualifications

• 12+ years in pharma or biotech quality
• Advanced a molecule from preclinical development through IND and into Phase 2 or beyond in a resource-constrained environment with substantial outsourced execution
• Deep expertise in either GMP or GCP with genuine working competence in the other
• Hands-on experience configuring or materially building a QMS such as ZenQMS, Veeva Vault QMS, Qualio, MasterControl, or TrackWise
• Strong grounding in data integrity and computer system validation fundamentals, including ALCOA+, 21 CFR Part 11, GAMP 5 categorization, and audit trail review
• Participated in sponsor-side FDA GMP or BIMO inspection

Nice to have

• Follow how regulators are approaching AI/ML in regulated environments
• Familiar with how AI/ML can be applied to informed discovery, biomarker selection, dose selection, or trial design

Benefits

• 401(k) plan with employer matching
• Medical, dental, and vision coverage
• Mental health and well-being support
• Open, flexible vacation policy
• Paid parental leave of at least 16 weeks for birth and 10 weeks for a new parent
• Quarterly budget for books and online courses
• Support to attend professional conferences
• New hire stipend for home office setup
• Monthly cell phone & internet stipend
• Access to free onsite baristas and daily lunch
• Access to a free commuter bus network

About the company

insitro is a drug discovery and development company using machine learning and data at scale to decode biology for transformative medicines. The company uses a Virtual Human platform and a TherML platform to identify genetic intervention points and translate them into therapeutics.