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. All our product candidates have been internally discovered using our ATTOBODY biparatopic biologics platform. Our ATTOBODY platform uses an evolution-driven, high-throughput process which allows for rapid discovery and creation of a high diversity of potential product candidates.
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, veteran or disability status.
Learn more about Attovia: www.attovia.com
Similar Jobs
Biotech • Pharmaceutical
Lead global GLP/GMP Quality Assurance strategy to transition from clinical development to commercial readiness. Build and manage GMP QA and QC Compliance teams, oversee audits/inspections, ensure regulatory compliance (FDA, EMA, ICH, NMPA), manage vendor oversight of CROs/CMOs/CDMOs, drive QMS processes (deviations, CAPA, change control, OOS/OOT), and advise executive leadership on quality risk and inspection readiness.
Top Skills:
CapaData IntegrityEmaFdaGlpGmpIchLaboratory Computerized SystemsNmpaOecdOosOotQuality Management System (Qms)
Biotech
Lead GCP quality for Prilenia's clinical programs from startup through inspection readiness. Oversee CRO and vendor QA, eTMF quality, CAPA resolution, audits, and regulatory inspection responses. Provide GVP and GLP QA oversight, author SOPs, define quality metrics, build a fit-for-purpose QMS, mentor QA staff, and represent QA in cross-functional governance.
Top Skills:
Electronic QmsEtmfVeeva VaultWingspan
.png)
Cloud • Insurance • Payments • Software • Business Intelligence • App development • Big Data Analytics
Lead design and governance of enterprise-scale data architecture (warehouses, lakehouses, streaming). Define standards for data quality, lineage, observability, and AI-enabled workflows. Mentor engineers, serve as technical escalation, and translate business needs into long-term data architecture and governance strategies.
Top Skills:
Data CatalogData PipelinesData WarehouseDbtFeature StoreGcp BigqueryLakehouseObservability/AlertingStreaming PlatformsVector Stores
What you need to know about the Los Angeles Tech Scene
Los Angeles is a global leader in entertainment, so it’s no surprise that many of the biggest players in streaming, digital media and game development call the city home. But the city boasts plenty of non-entertainment innovation as well, with tech companies spanning verticals like AI, fintech, e-commerce and biotech. With major universities like Caltech, UCLA, USC and the nearby UC Irvine, the city has a steady supply of top-flight tech and engineering talent — not counting the graduates flocking to Los Angeles from across the world to enjoy its beaches, culture and year-round temperate climate.
Key Facts About Los Angeles Tech
- Number of Tech Workers: 375,800; 5.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Snap, Netflix, SpaceX, Disney, Google
- Key Industries: Artificial intelligence, adtech, media, software, game development
- Funding Landscape: $11.6 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Strong Ventures, Fifth Wall, Upfront Ventures, Mucker Capital, Kittyhawk Ventures
- Research Centers and Universities: California Institute of Technology, UCLA, University of Southern California, UC Irvine, Pepperdine, California Institute for Immunology and Immunotherapy, Center for Quantum Science and Engineering
