Executive Director, Clinical Quality Assurance

Aura Biosciences•Boston, MA

4d•$240,000 - $305,000

About The Position

The Executive Director, GCP Quality Assurance provides strategic and functional leadership for GCP Quality across Aura Biosciences’ clinical development portfolio. This leader is accountable for establishing and advancing a risk-based, inspection-ready Clinical Quality framework that supports global clinical development and ensures compliance with applicable regulations, ICH guidelines, company procedures, and industry standards. The Executive Director serves as a senior Quality partner to Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, and other cross-functional leaders, providing independent quality oversight, risk assessment, and strategic guidance throughout the clinical development lifecycle. This role leads GCP inspection readiness and sponsor inspection activities, including FDA BIMO inspections, and provides quality oversight of CROs and other critical clinical partners. The Executive Director is a member of appropriate cross-functional governance and clinical leadership forums and serves as a key Quality advisor to senior management on clinical quality risks, compliance, inspection readiness, and overall quality strategy.

Requirements

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.

Nice To Haves

RQA-GCP certification and working knowledge of cGMP and GVP requirements are desirable; combination product experience preferred.

Responsibilities

Develop and lead the GCP Quality strategy and quality framework supporting Aura’s clinical development portfolio, with particular focus on pivotal and late-stage programs.
Establish and continuously improve a risk-based Clinical Quality Management System encompassing 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 on complex compliance and quality matters.
Establish GCP quality objectives, metrics, and leading indicators and provide strategic quality reporting, including contributions to Quality Management Review and senior leadership governance.
Identify emerging compliance and quality risks, assess their potential impact on clinical programs and regulatory submissions, and ensure appropriate escalation and remediation.
Promote a culture of quality, accountability, and proactive risk management across clinical development.
Provide strategic Quality oversight of global CROs, investigators, vendors, and other external partners supporting clinical development.
Establish risk-based qualification, oversight, monitoring, and ongoing performance assessment processes for GCP and GLP vendors, including Approved Vendor List governance.
Partner with Clinical Operations to ensure appropriate oversight of critical vendors and effective management of quality and compliance risks.
Provide Quality input into clinical development strategies, protocols, informed consent forms, Clinical Study Reports, and other key clinical documentation, as appropriate.
Ensure significant quality events, audit findings, and compliance issues are appropriately investigated, risk assessed, remediated, and trended.
Lead the development and execution of a risk-based GCP audit strategy encompassing clinical systems, processes, investigator sites, CROs, vendors, and computerized systems, as applicable.
Provide strategic oversight of audit observations, inspection findings, CAPAs, and remediation plans, ensuring actions are scientifically sound, risk-based, timely, and sustainable.
Identify systemic compliance trends and quality risks and drive cross-functional remediation and continuous improvement.
Provide senior-level oversight of root cause analysis, quality event management, CAPA effectiveness, and quality risk management.
Ensure GCP procedures, training, and quality processes evolve in response to regulatory expectations, inspection experience, organizational changes, and emerging industry practices.
Own and lead the GCP Inspection Readiness strategy for Aura’s clinical development programs.
Lead preparation for and hosting of FDA BIMO and other global regulatory inspections involving clinical operations and sponsor oversight.
Establish inspection readiness governance, training, mock inspections, BIMO interview preparation, document readiness, and cross-functional response processes.
Serve as the senior GCP Quality leader during regulatory inspections and provide strategic direction for inspection responses, commitments, and remediation.
Partner with Regulatory Affairs and Clinical leadership to ensure consistent, timely, and high-quality responses to regulatory inquiries and inspection observations.
Serve as the senior GCP Quality representative on appropriate clinical and cross-functional governance forums and provide an independent Quality perspective on program strategy and risk.
Build strong partnerships with Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, Data Management, Pharmacovigilance, and other relevant functions.
Influence senior leaders and functional stakeholders to prioritize and resolve significant quality and compliance risks.
Escalate critical compliance risks, systemic issues, or inadequate remediation to executive management with clear assessment of business and regulatory impact and recommended actions.
Represent Quality in strategic discussions with external partners, CROs, consultants, and other stakeholders.
Provide leadership, coaching, and development to GCP Quality personnel and contribute to the broader development of the Quality organization.
Establish the strategic approach for GCP training and compliance awareness across clinical development.
Ensure training requirements are appropriately aligned with roles, regulatory expectations, process changes, audit findings, inspection experience, and emerging risks.
Drive continuous improvement initiatives that strengthen clinical quality, simplify processes, and improve organizational effectiveness.
Partner with the Quality leadership team on enterprise-wide quality initiatives and provide GCP expertise to support an integrated Quality organization.
Provide GCP Quality support to GMP and other Quality activities when appropriate to business needs.