Attovia Therapeutics
Senior Director / Director, Quality Assurance
San Carlos, CA · Director
Sponsorship not specified$210k-$280kDetected 5 days ago
GCPAuditingControlsClinical TrialsGMPFDA RegulatoryCRISPRPharmacovigilanceAnimal StudiesLeadershipCollaborationWritingGxPBiostatisticsRegulatory Affairs
About the role
- Attovia Therapeutics, Inc., is seeking a Sr.
- All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Responsibilities
- Own quality oversight of CDMO activities, ensuring external partners operate in compliance with FDA, EMA, ICH, other applicable global regulations, and quality agreements.
- 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.
- 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.
Requirements
- 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.
- Experience reviewing batch records, CoAs, deviations, and change controls generated by external parties.
Nice to have
- Strong technical writing, investigative, and risk-assessment skills.
- Familiarity with electronic QMS platforms (e.g., Veeva QMS, MasterControl, TrackWise).
- Experience supporting a pre-approval inspection (PAI) or BLA/NDA filing.
- 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.
- Teamwork & Collaboration
- Attovia is located in San Carlos, CA.
- Attovia is an equal opportunity employer.
Compensation
- $210k-$280k
Company info
- Integrity
- Learning & Growth
- Drive for Excellence
- Innovation
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This listing is sourced directly from Attovia Therapeutics's careers page and normalized into a canonical job model.