DescriptionJOB TITLE: Associate Director, Clinical Quality AssuranceLOCATION: Boston, MA DATE PREPARED: November 9, 2026JOB SUMMARY: AVEO Oncology is seeking an experienced and self-motivated Associate Director, Clinical Quality Assurance to clinical quality assurance activities across our clinical development programs, from early to late stage development. Reporting to the Senior Director, Clinical Quality Assurance, this individual will lead Good Clinical Practice (GCP) oriented activities throughout the clinical development lifecycle, including the management of audits, quality issues and investigations, and inspections.
The Associate Director will partner closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and other cross-functional stakeholders to ensure that studies comply with company SOPs, policies, and applicable international regulations and guidelines (e.g., FDA, EMA, ICH GCP), while providing risk-based quality management and continuous improvement support, contributing to every facet of compliance and quality, from strategic planning to hands-on implementation, across multiple programs and studies.
The ideal candidate is a passionate clinical quality assurance professional with deep GCP expertise in the biotechnology or pharmaceutical industry, sound regulatory judgment, and the leadership and communication skills to work independently, operating both strategically and hands-on in a dynamic environment.
PRINCIPAL DUTIES: Clinical Quality Assurance & Compliance- Provide GCP quality oversight for clinical development programs to ensure compliance with FDA regulations, ICH guidelines, and applicable global regulatory requirements.
- Provide professional expertise and guidance on GCP, Good Laboratory Practices (GLP), and Good Pharmacovigilance Practices (GVP) regulations to clinical development teams, proactively identifying compliance issues and risks and recommending mitigations.
- Implement clinical quality strategy and risk-based GCP quality assurance strategies across clinical programs and studies, including program-specific risk-based audit plans.
- Provide Clinical QA review and oversight of clinical trial documents, including protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other study-specific documents as requested.
- Identify, assess, and escalate potential compliance risks and recommend appropriate corrective actions.
- Support the development, implementation, and continuous improvement of clinical quality processes, policies, and procedures.
- Stay current on new and revised regulations, industry trends, and regulatory interpretations through training, conferences, and industry forums.
Auditing & Vendor Oversight- Plan, conduct, and oversee GCP audits of clinical investigator sites, contract research organizations (CROs), vendors, and clinical systems.
- Manage external auditors and ensure timely completion of audit reports, findings, and corrective and preventive action (CAPA) plans.
- Provide input and expertise to clinical vendor risk assessments in support of vendor and service provider qualification, and provide quality oversight of CROs and other clinical service providers to ensure compliance with contractual and regulatory obligations.
- Partner with clinical stakeholders on vendor and site oversight and issue management.
- Evaluate audit findings, identify trends across programs, vendors, and sites, and partner with stakeholders to implement sustainable corrective actions.
Regulatory Inspections & Inspection Readiness- Lead and support clinical inspection readiness activities, including preparation of study teams, clinical sites, and significant clinical service providers for FDA and other health authority regulatory inspections.
- Coordinate inspection preparation, documentation review, and cross-functional readiness assessments, and provide GCP compliance technical support during inspections of AVEO and of investigator sites.
- Support the development of responses to inspection observations and implementation of remediation activities.
- Ensure clinical trial documentation and quality records are maintained in an inspection-ready state.
Quality Systems & Continuous Improvement- Support the management and enhancement of GCP-related quality management systems, including deviations, CAPAs, change controls, and quality risk assessments.
- Review and approve applicable clinical quality documentation and standard operating procedures (SOPs)
- Analyze, and report clinical quality metrics and trends for assigned programs to study teams and Quality leadership; recommend required actions, monitor implementation, and use insights to drive process improvement.
- Develop and deliver GCP training and promote a culture of quality and compliance throughout the organization.
- Collaborate with internal stakeholders to ensure consistent application of quality standards across clinical programs.
- Represent Quality in internal meetings and cross-functional process improvement initiatives, and build and maintain effective working relationships with internal and external partners.
BASIC QUALIFICATIONS:Education & Experience- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline required; advanced degree preferred.
- Minimum of 8-10 years of progressive experience in Clinical Quality Assurance, GCP compliance, or related quality functions within the biotechnology or pharmaceutical industry.
- Demonstrated experience conducting and managing GCP audits of clinical sites, CROs, and vendors.
- Experience developing and reviewing SOPs and controlled documents to ensure processes are accurately represented.
- Strong knowledge of FDA regulations, ICH-GCP guidelines, and global clinical trial regulatory requirements.
- Experience supporting regulatory inspections and clinical inspection readiness activities.
- Experience with quality management systems, CAPA management, deviation investigations, and risk-based quality oversight.
- Prior experience in oncology clinical development strongly preferred.
Skills & Competencies- Strong analytical, problem-solving, and risk-assessment capabilities.
- Excellent verbal and written communication and interpersonal skills with the ability to influence cross-functional stakeholders.
- Ability to manage multiple priorities and work independently in a fast-paced environment.
- Demonstrated ability to balance regulatory compliance requirements with practical business and clinical development needs.
- Strong organizational skills, attention to detail, and sound decision-making.
- Ability to build effective working relationships with internal teams, external partners, and regulatory stakeholders.
