At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery. By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.
Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.
Aura Biosciences is actively recruiting for a Manager/Sr. Manager, GCP Quality to support the Director, GCP Quality with all clinical quality activities in support of clinical trial execution of Aura’s drug development programs. This is a vital position in the success of Aura’s GCP function, including auditing, proactive study support and inspection readiness. The successful candidate will have a strong foundation in the planning, conduct, reporting and close out of GCP audits (e.g. Investigator Site, Clinical Process, TMF, Database, Clinical Suppliers) and proactive GCP support of ongoing trials in all phases with both internally sourced and CRO outsourced trials. Experience in internal Quality Event Management and CAPA, sponsor Regulatory Health Inspections and inspection readiness planning is highly desired.
Responsibilities include but are not limited to:
- Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation).
- Conduct external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs).
- Track and review audit responses and ensure acceptability of CAPAs.
- Provide guidance to Clinical Operations staff and other GCP-related departments, as applicable, based.
- interpretation of current regulations to ensure best practices including risk-based management.
- Assist in the development of Inspection Readiness program and assist senior staff during regulatory inspections.
- Work closely with Clinical Operations on assigned studies to provide proactive GCP compliance support.
- Support clinical Quality Event and CAPAs with review of investigation, root cause and implementation planning and timeliness.
- Assist with departmental metrics trending and reporting.
- Support creation or revision of SOPs, WIs, templates and forms.
- Review protocols, monitoring plans, ICFs, other study related forms as required.
- BS in a life science field required
- 5-8 years (8 years for senior) of direct GCP pharmaceutical/biotechnology experience and auditing
- RQAP-GCP certification desired, or willingness to obtain certification
- Solid understanding and application of FDA regulations, ICH/GCP, GLP, MHRA, EMA, Health Canada.
- Excellent written and oral communications skills
- A well organized, self-motivated and independent work style Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
- Ability and willingness to travel domestically and internationally for audits
Aura offers a great benefit package which includes:
- Health insurance with FULL premium coverage
- 401K with company match
- Competitive Paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
- Free parking
Interested in applying? Please apply through our LinkedIn posting: https://www.linkedin.com/jobs/view/3191677256