Quality Compliance Associate, GMP

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 Quality Compliance Associate, GMP. The successful candidate will have extensive experience in batch record review and disposition, Quality Systems (Change Control, Deviations, CAPAs, etc.) and proactive GMP support of ongoing trials in all phases. Ophthalmology and/or oncology and medical device experience desired, but not required.  This candidate will support the Director, GMP Quality in supporting the GMP activities in the execution of Aura’s drug development programs.

Responsibilities include but are not limited to:

  • Work collaboratively with our technical, manufacturing and quality operation teams, as well as CMOs, to ensure Deviation, Investigation & CAPA outputs are accurate, thorough, effective and on-time.
  • Provide subject matter expertise for systematic and analytical root cause analysis techniques and principles.
  • Support inspections, due diligence and internal audits as Deviation, Investigation & CAPA Quality System subject matter expert.
  • Support Deviation, Investigation & CAPA Quality Systems, processes, procedures and eQMS software external manufacturing.
  • Provide guidance and training for technical authoring and reviewing of deviations, investigations/root cause analysis and CAPAs.
  • Develop KPIs and metrics for periodic trend reviews and present to senior management

Minimum Requirements:

  • BS in a life science field required.
  • 5+ years of direct GMP pharmaceutical/biotechnology manufacturing experience
  • Solid understanding and application of FDA regulations, ICH/GMP, GLP, MHRA, EMA, Health Canada.
  • Excellent written and oral communications skills
  • Previous experience writing and approving deviations, CAPAs, change controls and OOS investigations
  • 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 to manage changing priorities in a fast-paced environment

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