Manager, GCP Quality

About Aura: 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.

Position Summary:

Aura Biosciences is actively recruiting for a Manager, GCP Quality. The successful candidate will have extensive experience 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. Ophthalmology and/or oncology experience desired, but not required. This candidate will support the Director, GCP Quality in supporting the audit activities of clinical trials in the execution of Aura’s drug development programs.

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.

on 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.
  • 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.

Minimum Requirements:

  • BS in a life science field required.
  • 5 years of direct GCP pharmaceutical/biotechnology experience and auditing
  • RQAP-GCP certification desired
  • 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 with the ability to initiate and follow through on assignments.
  • 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

Interested? Email a cover letter and a copy of your CV to referencing the position description in the subject line.