Director or Senior Director, Quality Assurance (GMP Vendor Quality) - Onsite San Carlos, CA

About the Role

Attovia Therapeutics, Inc. is seeking a Director or Senior Director of Quality Assurance to lead our quality function and strengthen oversight of external CDMO/CRO partners who perform much of our GMP manufacturing, testing, and clinical work. Reporting to the Quality Officer, you will ensure that outsourced activities are integrated into an inspection-ready compliance picture and consistently meet regulatory expectations.

Responsibilities

• Lead vendor quality management, including qualifying and auditing CDMOs/CROs
• Negotiate, establish, and maintain Quality Agreements with external partners
• Perform final quality review to support batch release and lot disposition
• Ensure the internal Quality Management System (QMS) effectively covers outsourced activities end-to-end
• Partner with CMC, Clinical Operations, Nonclinical/Preclinical Development, and Regulatory Affairs to align quality oversight with project needs
• Drive a risk-based approach to ensure outsourced work protects patient safety and meets GMP and regulatory requirements

Requirements

• Significant experience in Quality Assurance within regulated environments (e.g., GMP and/or clinical quality)
• Proven experience overseeing external vendors/partners, including audits and qualification activities
• Strong knowledge of quality agreements, batch release/lot disposition processes, and inspection readiness
• Ability to collaborate cross-functionally with CMC, Clinical, Nonclinical, and Regulatory teams
• Experience working with quality systems and ensuring compliance across outsourced operations

Benefits

• Opportunity to lead a critical quality function in a growing therapeutics organization
• Collaborate with cross-functional teams to support compliant, high-quality development and manufacturing
• Contribute to patient safety through robust vendor oversight and quality decision-making