(Sr.) Manager, GCP Quality Assurance
Aura Biosciences
August 21, 2026
Remote friendly (Boston, MA)
United States
Operations
Responsibilities:
- Provide strategic GCP quality oversight and consultation to study teams; apply regulatory requirements, quality standards, and risk-based management principles.
- Perform and/or manage GCP audits of CROs, vendors, investigator sites, TMFs, and internal R&D processes; assess root cause analyses and CAPA effectiveness; drive timely resolution of audit observations.
- Oversee clinical quality events, deviations, investigations, and CAPAs with risk-based evaluation, comprehensive root cause analysis, effective remediation, and trend analysis.
- Support development, maintenance, and continuous improvement of the Clinical Quality Management System (QMS), including quality policies, SOPs, and training.
- Support inspection readiness and provide quality support during regulatory inspections of Aura and investigator sites.
- Attend internal/external study team calls and ad hoc quality calls.
- Conduct risk-based reviews of clinical trial documents for regulatory/GCP compliance and inspection readiness expectations.
- Assist with departmental metrics trending and reporting.
Qualifications (Minimum):
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field (advanced degree a plus); equivalent experience considered.
- 6–10+ years clinical research/pharmaceutical/biotechnology experience.
- 5+ years in Clinical Quality Assurance or Clinical Compliance, including audits of clinical sites and clinical services vendors.
- Solid global clinical trial conduct experience; knowledge of ICH, FDA, MHRA, EU, and Health Canada requirements.
- Excellent interpersonal and written/oral communication skills.
- Ability/willingness to travel domestically and internationally for audits.
- Regulatory authority inspection support experience preferred.
Preferred:
- GLP and/or GVP experience.
Benefits (as stated):
- Salary range: $130,000/yr–$185,000/yr.
- Health insurance with FULL premium coverage; 401K with company match; ESPP; competitive PTO; company-paid short & long-term disability insurance and life insurance.
- Provide strategic GCP quality oversight and consultation to study teams; apply regulatory requirements, quality standards, and risk-based management principles.
- Perform and/or manage GCP audits of CROs, vendors, investigator sites, TMFs, and internal R&D processes; assess root cause analyses and CAPA effectiveness; drive timely resolution of audit observations.
- Oversee clinical quality events, deviations, investigations, and CAPAs with risk-based evaluation, comprehensive root cause analysis, effective remediation, and trend analysis.
- Support development, maintenance, and continuous improvement of the Clinical Quality Management System (QMS), including quality policies, SOPs, and training.
- Support inspection readiness and provide quality support during regulatory inspections of Aura and investigator sites.
- Attend internal/external study team calls and ad hoc quality calls.
- Conduct risk-based reviews of clinical trial documents for regulatory/GCP compliance and inspection readiness expectations.
- Assist with departmental metrics trending and reporting.
Qualifications (Minimum):
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field (advanced degree a plus); equivalent experience considered.
- 6–10+ years clinical research/pharmaceutical/biotechnology experience.
- 5+ years in Clinical Quality Assurance or Clinical Compliance, including audits of clinical sites and clinical services vendors.
- Solid global clinical trial conduct experience; knowledge of ICH, FDA, MHRA, EU, and Health Canada requirements.
- Excellent interpersonal and written/oral communication skills.
- Ability/willingness to travel domestically and internationally for audits.
- Regulatory authority inspection support experience preferred.
Preferred:
- GLP and/or GVP experience.
Benefits (as stated):
- Salary range: $130,000/yr–$185,000/yr.
- Health insurance with FULL premium coverage; 401K with company match; ESPP; competitive PTO; company-paid short & long-term disability insurance and life insurance.