Senior Director / Director of Quality Assurance

About the Role

Attovia Therapeutics, Inc., is recruiting a Senior Director or Director to lead the Quality Assurance function, specifically overseeing external CDMO and CRO partners responsible for GMP manufacturing, testing, and clinical operations. Reporting to the Quality Officer, this role is critical in managing vendor quality through qualification, audits, negotiation of Quality Agreements, and final quality control for batch release decisions. This position ensures the company's Quality Management System (QMS) integrates all outsourced activities into a unified compliance framework ready for inspections.

Key Responsibilities

• Collaborate with Quality Officer, CMC, and clinical leaders to define strategic priorities for the quality department.
• Represent Quality in regulatory discussions, partnership evaluations, and vendor selections.
• Lead oversight of CDMO activities ensuring compliance with FDA, EMA, ICH, and other global regulations and quality agreements.
• Review and approve vendor batch records, protocols, and quality documents to confirm GMP adherence and complete quality records for product release.
• Implement proactive risk-based supervision of CDMO quality systems including deviations, investigations, CAPAs, and change controls.
• Support technology transfer and validation processes at CDMO sites to prepare manufacturing for commercialization.
• Provide oversight on GCP/GLP compliance of clinical and nonclinical CROs, assuring rigorous adherence to regulatory standards.
• Monitor clinical QA documentation and audit findings, partnering with clinical QA consultants to manage quality issues and vendor oversight plans.
• Conduct vendor qualifications and audits to ensure readiness for inspections and maintain updated Quality Agreements.
• Develop and enhance internal QMS frameworks spanning SOPs for vendor management, deviations, CAPA, change control, document management, pharmacovigilance, and training.
• Maintain document control systems for all quality-related documents and agreements.
• Lead annual GxP training initiatives and promote a strong risk-conscious quality culture across the organization.

Basic Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Chemistry, Engineering, or a related technical field.
• Experience in biologics, cell and gene therapy, or sterile injectable manufacturing environments.
• Over 12 years of Quality Assurance experience in biotech or pharmaceutical industries with direct management of outsourced GMP manufacturing/testing relationships; CDMO experience mandatory.
• Thorough knowledge of global GMP regulations including FDA, EMA, ICH, and applicable GCP/GLP standards.
• Proven capability in auditing contract manufacturers and CROs, and managing Quality Agreements.
• Familiar with reviewing batch records, Certificates of Analysis, deviations, and change controls from external partners.

Preferred Qualifications

• Strong skills in technical documentation, investigations, and risk assessments.
• Ability to operate independently managing multiple vendor relationships with minimal supervision.
• Experience as the sole or lead Quality Assurance function in a small or virtual biotech.
• Prior exposure to electronic QMS platforms such as Veeva QMS, MasterControl, or TrackWise.
• Participation in pre-approval inspections or supporting BLA/NDA regulatory filings.

About Attovia Therapeutics

Attovia is a clinical-stage biopharmaceutical company focused on developing novel biotherapeutics targeting immune-mediated diseases with high unmet needs. Their product pipeline is based on the proprietary ATTOBODY biparatopic platform which enables rapid generation of diverse candidates using an evolution-driven, high-throughput methodology.

The company culture is anchored on Integrity, Learning & Growth, Excellence, Innovation, and Teamwork. Attovia prioritizes fostering an inclusive and dynamic workplace, welcoming applicants from diverse backgrounds.

Additional Information

The position is located in San Carlos, CA, and is a full-time onsite role. Attovia is an equal opportunity employer committed to nondiscriminatory hiring based on race, color, religion, gender identity, sexual orientation, veteran status, or disability.

Artificial intelligence tools may assist in application reviews and process facilitation; however, final decisions rest with human personnel. Salary and leveling depend on experience.