Executive Director, Clinical Quality Assurance

Aura Biosciences

. Develop and lead the GCP Quality strategy and quality framework supporting Aura Biosciences’ clinical development portfolio, focusing on pivotal and late-stage programs .

Posted 9/15/2026full-timeBrighton • Massachusetts • United StatesLead💰 $240,000 - $305,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in GCP Quality Assurance, including the development and leadership of quality strategies, risk management, and regulatory inspection readiness. Proven ability to influence cross-functional teams and manage complex quality systems within the pharmaceutical and biotechnology sectors.

Highest-signal resume keywords

GCP Quality AssuranceRegulatory Inspection ReadinessRisk ManagementCAPA ManagementGlobal CRO Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCPICHFDAQuality Management SystemAuditingClinical DevelopmentClinical OperationsQuality MetricsRisk-Based Decision MakingInspection Readiness

Soft Skills

LeadershipInfluencingCoachingStrategic ThinkingCollaboration

Certifications & Qualifications

RQA-GCP

Industry Keywords

PharmaceuticalBiotechnologyClinical ResearchRegulatory AffairsCAPABIMOQuality EventsVendor OversightContinuous ImprovementDrug Development

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop and lead the GCP Quality strategy and quality framework supporting Aura Biosciences’ clinical development portfolio, focusing on pivotal and late-stage programs
Establish and continuously improve a risk-based Clinical Quality Management System covering auditing, quality events, CAPA, issue management, training, vendor oversight, and continuous improvement
Provide independent Quality leadership and strategic counsel to Clinical Operations, Clinical Development, Regulatory Affairs, and other GCP functions
Establish GCP quality objectives, metrics, leading indicators, and strategic quality reporting
Identify, assess, escalate, and remediate emerging compliance and quality risks
Provide strategic Quality oversight of global CROs, investigators, vendors, and other external partners
Establish risk-based qualification, oversight, monitoring, and performance assessment processes for GCP and GLP vendors
Provide Quality input into clinical development strategies, protocols, informed consent forms, Clinical Study Reports, and other clinical documentation
Lead risk-based GCP audits across clinical systems, processes, investigator sites, CROs, vendors, and computerized systems
Oversee audit observations, inspection findings, CAPAs, remediation plans, root cause analysis, quality event management, and CAPA effectiveness
Own and lead GCP Inspection Readiness strategy
Lead preparation for and hosting of FDA BIMO and other global regulatory inspections
Establish inspection readiness governance, training, mock inspections, BIMO interview preparation, document readiness, and response processes
Serve as senior GCP Quality leader during regulatory inspections and direct inspection responses and remediation
Represent Quality on clinical and cross-functional governance forums and advise senior management
Build partnerships across Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, Data Management, Pharmacovigilance, and other functions
Provide leadership, coaching, and development to GCP Quality personnel
Establish the strategic approach for GCP training and compliance awareness
Drive continuous improvement initiatives and support enterprise-wide Quality initiatives

Requirements

What you’ll need

Bachelor’s degree in a life science or related field required; advanced degree preferred
15+ years of progressive experience in GCP Quality Assurance within the pharmaceutical or biotechnology industry, including significant leadership experience supporting global clinical development
Demonstrated experience leading GCP Quality strategy for late-stage/pivotal clinical programs and preparing organizations for regulatory inspections
Extensive knowledge and practical application of GCP, ICH, FDA, and applicable international clinical research requirements, including ICH E6
Proven experience with global CRO and clinical vendor oversight, risk management, auditing, CAPA, quality systems, and inspection readiness
Demonstrated experience leading FDA BIMO and/or other global regulatory inspections
Strong understanding of drug and biologic development, clinical operations, and the regulatory development lifecycle
Broad understanding of nonclinical and CMC/manufacturing processes and their relationship to overall product development
Strong executive presence with demonstrated ability to influence senior leaders and cross-functional stakeholders
Demonstrated ability to make sound, risk-based decisions in complex and rapidly changing environments
Ability to manage multiple strategic priorities and operate effectively with ambiguity and incomplete information
Ability to travel domestically and internationally as required
RQA-GCP certification and working knowledge of cGMP and GVP requirements are desirable; combination product experience preferred

Benefits

Comp & perks

Health insurance with FULL premium coverage
401K with company match
Employee Stock Purchase Program (ESPP)
Unlimited paid time off (PTO)
Company-paid short & long-term disability insurance and life insurance