Director, GxP Quality

3 weeks ago

Boston MA, United States Third Rock Ventures Full time

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts

Summary

Tango Therapeutics has an exciting new opportunity to join the team as Director, GXP Quality to manage quality assurance GXP activities (excluding GMP). Your primary responsibilities, of this first in role position, will be to ensure quality and compliance of Tango's development programs with respect to QMS management, controlled documents, and applicable regulatory requirements (FDA/ICH/EMEA, and current industry standards and practices) as well as support the non-clinical team to ensure GLP studies are conducted in a compliant manner. In this role you will report to the Head of Development Operations.

Your role:

  • You will provide GCP/GLP/GVP QA oversight and support to cross functional teams
  • Schedule, oversee, and follow through routine and non-routine quality assurance audits including: investigator sites, CROs/ vendors, process, system, study project, and document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines; will include conducting audits
  • Chair committee for the development, review, and approval of GCP/GLP/GVP controlled documents
  • Develop and implement detailed audit plans and yearly GCP/GLP/GVP audit schedules
  • Ensure timely and effective follow up of all identified or assigned quality issues
  • Act as a liaison with QA counterpart at CROs/vendors
  • Together with cross functional stakeholders assist in preparing for regulatory inspections
  • Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents
  • Conduct QA review of GLP reports and validation plans
  • Additional duties and responsibilities as required

What you bring:

  • Bachelor's Degree in a scientific discipline; advanced degree preferred
  • At least 8 years in the pharmaceutical industry with 5 years in GCP QA
  • Solid understanding of GCP, GLP, GVP, and ICH clinical requirements
  • Experience with US and international clinical studies
  • Able to travel domestically and internationally approximately 25% of the time
  • Excellent verbal and written communication skills including review of clinical documents
  • Good organizational skills and ability to work independently
  • Collaborative problem-solver

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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