Lead and scale QA for a clinical-stage biotech, overseeing CDMO/CRO vendor qualification, audits, Quality Agreements, batch release review, QMS development, and GxP oversight across manufacturing, clinical, and nonclinical activities to ensure regulatory compliance and patient safety.
Attovia Therapeutics, Inc., is seeking a Sr. Director/Director of Quality Assurance to lead our quality function and oversee the performance of our external CDMO/CRO partners, who execute the majority of our GMP manufacturing, testing, and clinical activities. Reporting directly to the Quality Officer, this role is responsible for vendor quality management: qualifying and auditing CDMOs/CROs, negotiating and maintaining Quality Agreements, performing final quality review for batch release and lot disposition, and ensuring the company's internal Quality Management System (QMS) ties together all outsourced activity into a single, inspection-ready compliance picture. This role partners closely with CMC, Clinical Operations, Nonclinical/Preclinical Development, and Regulatory Affairs teams to ensure that our outsourced partners consistently deliver compliant, high-quality work that meets regulatory expectations and protects patient safety.
Key Responsibilities
- Working closely with the Quality Officer, CMC and clinical leadership, help set strategic direction and priorities for the quality function.
- Represent Quality in regulatory strategy discussions, partnership/licensing diligence, and CDMO/CRO selection decisions.
- Own quality oversight of CDMO activities, ensuring external partners operate in compliance with FDA, EMA, ICH, other applicable global regulations, and quality agreements.
- In partnership with the CMC team, review and approve CDMO executed batch records, protocols, and quality documentation, confirming that all GMP requirements are met and that the quality record supporting each batch release decision is complete and traceable.
- Drive proactive, risk-based oversight of CDMO quality systems, including deviations, investigations, CAPAs, change controls.
- Support technology transfer and process validation activities performed at CDMO sites, including protocol/report review and approval to ensure manufacturing readiness for commercialization.
- Provide GCP/GLP quality oversight of CROs supporting clinical trials and nonclinical/toxicology studies to ensure all activities are conducted in strict compliance with FDA, EMA, ICH, other applicable global regulations, and quality agreements.
- Working with Clinical QA consultant, review clinical quality documentation, monitor CRO audit findings, and track resolution of quality issues affecting trial data integrity.
- Partner with Clinical Operations and Clinical QA consultants to ensure vendor oversight plans and risk-based monitoring approaches remain aligned with GCP requirements.
- Provide support for clinical deviations and CAPA management. Identify and assess compliance risk and develop and implement risk mitigation measures.
- Drive vendor audits and qualification to ensure external partners maintain compliant, inspection-ready systems
- Draft, negotiate, and maintain Quality Agreements defining roles, responsibilities, and quality standards between the company and each vendor.
- Maintain the approved vendor list and associated risk assessments.
- Working across internal functions and with external clinical/nonclinical QA consultants, drive the development of the internal QMS, including SOPs governing vendor oversight, deviations, CAPA, change control, document control, clinical operations, data management, pharmacovigilance, biostatistics, and training, and continuously improve it to support scaling clinical pipelines.
- Maintain document control systems for controlled documents, quality agreements, and vendor quality records.
- Training & Quality Culture
- Develop and deliver GxP yearly training for internal staff, and champion a strong, risk-based quality culture across a small, cross-functional organization.
Quality Strategy & Leadership
CDMO Quality Oversight
Clinical & Nonclinical CRO Oversight
Vendor Qualification, Audits & Quality Agreements
Quality Management System (QMS)
Basic Qualifications
- Bachelor's or Master's degree in Life Sciences, Chemistry, Engineering, or a related technical discipline.
- Experience in biologics, cell & gene therapy, or sterile injectable products.
- 12+ years of Quality Assurance experience in the biotech/pharmaceutical industry, with direct experience managing outsourced GMP manufacturing and/or testing relationships (CDMO experience required).
- Strong working knowledge of global GMP requirements including FDA, EMA, ICH guidelines, and applicable GCP/GLP regulations.
- Demonstrated experience auditing contract manufacturers, testing labs, depot, or CROs, and negotiating Quality Agreements.
- Experience reviewing batch records, CoAs, deviations, and change controls generated by external parties.
Preferred Qualifications
- Strong technical writing, investigative, and risk-assessment skills.
- Ability to work independently and manage multiple vendor relationships with minimal direct supervision
- Prior experience as the sole or lead quality function at a small or virtual biotech company.
- Familiarity with electronic QMS platforms (e.g., Veeva QMS, MasterControl, TrackWise).
- Experience supporting a pre-approval inspection (PAI) or BLA/NDA filing.
About Attovia
Attovia™ is a clinical-stage biopharmaceutical company developing next-generation biotherapeutics for immune-mediated diseases with high unmet need. Our product candidates are internally discovered using our proprietary ATTOBODY™ platform, an evolution-driven, high-throughput biologics platform that enables the rapid discovery and creation of diverse biparatopic complex biologics. Our pipeline spans chronic pruritic diseases, inflammatory skin diseases, inflammatory bowel disease, and other immune-mediated conditions.
Our culture is centered around five core pillars:
• Integrity
• Learning & Growth
• Drive for Excellence
• Innovation
• Teamwork & Collaboration
We take pride in fostering a strong team and dynamic work environment, and we are seeking individuals who align with our values and contribute to a positive and impactful workplace.
Attovia is located in San Carlos, CA.
Attovia is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, or veteran or disability status.
Learn more about Attovia: www.attovia.com
Attovia Therapeutics San Carlos, California, USA Office
1091 Industrial Rd, Suite 310, San Carlos, California, United States, 94070
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