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
Skills Required
- Bachelor's or Master's degree in Life Sciences, Chemistry, Engineering, or 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, depots, or CROs, and negotiating Quality Agreements
- Experience reviewing batch records, Certificates of Analysis (CoAs), deviations, and change controls generated by external parties
- 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
What We Do
Attovia is creating a pipeline of biotherapeutics for the treatment of immune-mediated diseases. We leverage ATTOBODY™, our proprietary biologics platform, to generate potentially first-in-class and best-in-class multi-specifics. ATTOBODIES utilize spatial positioning technology to achieve biparatopic target engagement. The biparatopic binding mode of ATTOBODIES results in ultra-high affinity, which translates to best-in-class potency in biologic activity. ATTOBODIES offer unconstrained engineering, making them an ideal modality for the development of multi-specific biologics, with tunable half-life translating to the potential for quarterly or less frequent dosing in patients. The high-throughput, evolution-based ATTOBODY discovery platform delivers a high degree of diversity at industry-leading speed, accelerating and de-risking therapeutics development, offering the potential to become the next-generation modality of choice. Learn more at www.attovia.com.
