Careers

Manager/Associate Director of Quality, GCP

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.

Location:

Based in the Company’s North Cambridge office, with <20% travel required.

Position Summary:

The GCP Quality Assurance candidate will manage activities related to the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by Aura Biosciences. The primary responsibilities will be to ensure both quality and compliance of company sponsored clinical trials with respect to internal Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices.

Responsibilities include but are not limited to:

  • Write and/or review SOPs to assess consistency and compliance with regulatory requirements/internal standards and determine/ensure effective implementation across the organization.

  • 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.

  • Provide guidance with the identification and management of risks in clinical trial activities and monitor/evaluate risk management activities.

  • Work closely with Clinical Operations and other GCP-related departments, as applicable, to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues in a timely manner, including approval of corrective action/preventative action (CAPA) plans, as necessary.

  • Participate in the review of drug safety practices for clinical trial compliance.

  • Identify need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs).

  • Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process

  • Provide functional review of clinical protocols, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents.

  • Collaborate with applicable departmental heads to identify clinical trial and regulatory training needs of Clinical Operations (and other Clinical trial members) based on regulatory changes, process/system changes, audit findings, trends, etc., and assist in coordinating the training to meet the needs.

  • Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation.  As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management.

  • Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management.

  • Provide guidance with the development and management of key vendor oversight activities for clinical trials and monitor/evaluate the oversight activities.

  • Assist senior staff during regulatory inspections

  • Ability to travel domestic and international.

  • Assist the Quality Unit with tasks related to GMP activities when required.

Minimum Requirements:

  • BS in a life science field required.

  • At least 5 years of direct GCP pharmaceutical/biotechnology experience.

  • Solid understanding and application of GCP, GLP and ICH requirements, especially ICH E6R2 as well as Canadian trial regulations

  • 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

  • The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events

  • Understanding of the drug and biologic development and clinical research processes

  • General understanding of non-clinical research and manufacturing processes including terminology

  • Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance and GCP auditing.

  • Working knowledge of cGMP processes and relevant regulations is a plus.

How we Work:

Aura is powered by a passion for bringing together diverse people, ideas and technologies behind common purpose: to create breakthroughs in diseases with significant unmet medical needs.  We constantly seek opportunities to broaden our impact and reach, using new platforms and technologies, and partnering to ensure that our drug development expertise reaches its full therapeutic potential.

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