Director/Senior Director, Quality Assurance

Position Summary

Tenaya Therapeutics is seeking a Director or Senior Director, Quality Assurance (QA) to provide strategic, phase-appropriate quality leadership in support of Tenaya’s clinical-stage programs. This role is responsible for ensuring GxP compliance across GMP, GCP, and GLP activities through a risk-based, highly outsourced operating model.

The position will serve as a key cross-functional partner, providing independent QA oversight across internal teams and external partners, including CROs, CMOs, and other vendors. This individual will play a critical role in inspection readiness, quality systems governance, and driving fit-for-purpose quality processes aligned with Tenaya’s current stage and business priorities.

This role is focused on GxP Quality Assurance and Quality Control (QC) oversight and systems.

Responsibilities 

• Provide independent GxP QA oversight across GMP, GCP, and GLP activities in support of clinical development programs
• Oversee quality activities performed by external partners, including CROs, CMOs, CDMOs, and contract laboratories
• Establish and maintain Quality Agreements to ensure clear roles, responsibilities, and compliance expectations
• Lead and manage the GxP audit program (internal and external), including vendor qualification and ongoing oversight
• Maintain and continuously improve phase-appropriate, fit-for-purpose Quality Management Systems (QMS)
• Oversee eQMS processes including document control, change control, deviations, CAPAs, complaints, and batch disposition
• Ensure data integrity and compliance through QA oversight of activities conducted by internal teams and external vendors
• Disposition (approve/reject) clinical batches in accordance with regulatory requirements
• Lead inspection readiness strategy and execution for FDA (including CBER) and other global regulatory inspections
• Serve as the primary Quality representative during regulatory inspections and audits
• Lead response development for regulatory observations, including root cause analysis and CAPA implementation
• Implement risk-based QA approaches to prioritize oversight across development activities
• Conduct targeted  quality risk assessments across programs and functions
• Communicate quality risks, trends, and mitigation strategies to senior leadership