Senior Manager, GCP Quality Assurance

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $130k - $185k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Aura Biosciences

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Aura Biosciences is a biotechnology company focused on developing innovative cancer treatments. It is currently enrolling patients in the global Phase 3 CoMpass trial to evaluate the safety and efficacy of belzupacap sarotalocan (bel-sar) for treating small choroidal melanoma. The company utilizes a novel Virus-Like Drug Conjugates (VDCs) platform to target various solid tumors, with an emphasis on ocular and urologic oncology. Aura Biosciences aims to create a new standard of care in cancer treatment by offering early intervention options that preserve patient vision and improve long-term outcomes. The company is actively involved in research and clinical trials to address cancers like choroidal melanoma and non-muscle-invasive bladder cancer.

📋 Description

• Provide strategic GCP quality oversight and consultation to study teams across all phases of clinical trial execution • Perform and/or manage GCP audits of CROs, vendors, investigator sites, Trial Master Files, and internal R&D processes • Assess root cause analyses and CAPA effectiveness and drive timely resolution of audit observations and quality issues • Oversee clinical quality events, deviations, investigations, and CAPAs, including risk-based evaluation, remediation, and trend analysis • Support development, maintenance, and continuous improvement of the Clinical Quality Management System, including quality policies, SOPs, and training programs • 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 • Conduct risk-based quality reviews of clinical trial documents • Assist with departmental metrics trending and reporting

🎯 Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field; equivalent professional experience will be considered • Advanced degree a plus • 6-10+ years clinical research/pharmaceutical/biotechnology experience • 5+ years experience in a Clinical Quality Assurance or Clinical Compliance role • Experience 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 communication skills • Ability and willingness to travel domestically and internationally for audits, if required • Previous experience supporting Regulatory Authority Inspections preferred • GLP and/or GVP experience is a plus

🏖️ Benefits

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