(Sr.) Manager, GCP Quality Assurance

Aura Biosciences•Boston, MA

1d•$130,000 - $185,000

About The Position

Aura Biosciences is seeking a (Sr.) Manager, GCP Quality Assurance to support the execution of clinical trials across its drug development programs. This role is responsible for providing quality oversight and assurance to safeguard patient safety and data integrity while supporting the implementation and continuous improvement of Aura’s quality framework. The position plays a key role in ensuring regulatory compliance, maintaining inspection readiness, and driving quality excellence across clinical operations. As a critical member of the GCP Quality function, the (Sr.) Manager will provide proactive support for ongoing clinical studies, contribute to internal quality initiatives and procedures, lead and/or support GCP audits, and help ensure organizational inspection readiness. The successful candidate will bring strong GCP Quality experience across the planning, execution, reporting, and follow-up of audits, including Investigator Site, Clinical Process, TMF, Database, and Clinical Vendor/Supplier audits. The ideal candidate will also have hands-on experience providing proactive quality support for clinical trials across all phases of development, including both sponsor-managed and CRO-outsourced studies. Experience in Quality Event Management, CAPA development and oversight, regulatory health authority inspections, and inspection readiness planning is highly desirable.

Requirements

Bachelor's degree in life sciences, nursing, pharmacy, or a related field (advanced degree a plus). Equivalent professional experience will be considered.
6-8+ years clinical research/pharmaceutical/biotechnology experience.
5+ years experience in a Clinical Quality Assurance or Clinical Compliance role, including experience in conducting audits of clinical sites and vendors providing clinical services.
Solid experience with global clinical trial conduct, knowledge and understanding of applicable ICH Guidelines, FDA Regulations, and MHRA, EU and Health Canada Requirements.
Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.
Excellent written and oral communications skills
Ability and willingness to travel domestically and internationally for audits, if required.

Nice To Haves

Previous experience in supporting Regulatory Authority Inspections preferred.
GLP and/or GVP experience is a plus

Responsibilities

Provide strategic GCP quality oversight and consultation to study teams, ensuring the effective application of regulatory requirements, quality standards, and risk-based management principles across all phases of clinical trial execution.
Perform and/or manage GCP audits of CROs, vendors, investigator sites, Trial Master Files (TMFs) and internal R&D processes, including assessment of root cause analyses and CAPA effectiveness, while driving the timely resolution of audit observations and quality issues.
Oversee the management of clinical quality events, deviations, investigations, and CAPAs, ensuring risk-based evaluation, comprehensive root cause analysis, effective remediation, and trend analysis to proactively identify systemic issues.
Support the development, maintenance, and continuous improvement of the Clinical Quality Management System (QMS), including quality policies, SOPs, and training programs, to ensure alignment with applicable regulatory requirements, industry standards, and organizational objectives.
Support inspection readiness activities and provide quality support during regulatory inspections of Aura and participating investigator sites.
Attend routine internal and external clinical study team and ad hoc calls in support of ongoing quality oversight.
Conduct risk-based quality reviews of clinical trial documents to ensure compliance with applicable regulatory requirements, GCP standards, Aura procedures, and inspection readiness expectations.
Assist with departmental metrics trending and reporting.