Director/Senior Director, GCP Quality Assurance

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

The Director, GCP & GLP QA, reporting to the Executive Director, Quality, is responsible for leading quality assurance oversight across clinical and nonclinical programs to ensure compliance with GCP, GLP, and global regulatory requirements. This role oversees audit strategy and execution, vendor and CRO quality management, inspection readiness, quality events/CAPAs, and compliance processes across clinical trials and laboratory operations. Partnering cross-functionally across the organization, the Director will help drive quality excellence, support regulatory inspections and submissions, and provide strategic QA guidance to internal teams and external partners. It’s an exciting time to join Tango as the company continues to advance its pipeline and strengthen its quality and compliance capabilities.

Your Role

Define and execute risk-based GCP audit strategy (CROs, sites, vendors, systems, and processes)

Provide QA consultation for protocol compliance, trial conduct, TMF/essential document readiness, and vendor oversight

Provide QA oversight of GLP studies at contract research laboratories, including facility/study audits and data integrity checks

Ensure GLP study documentation supports regulatory submissions and is inspection-ready

Oversee quality events impacting GCP/GLP (e.g., serious breaches, deviations)

Lead investigations, root cause analysis, and CAPA development,

Establish relationships with vendor and partner QA to ensure quality agreements/oversight plans are in place and performance is monitored

Support qualification and ongoing oversight of CROs, central labs, imaging vendors, eCOA/IRT providers, etc.

Lead preparation activities for clinical/nonclinical inspections (BIMO, GCP, GLP), including mock inspections and evidence room support

Coordinate responses to clinical/nonclinical inspection observations in collaboration with stakeholders

Ensure GCP/GLP-related SOPs and training curricula are current, role-based, and effectively implemented

Provide coaching and quality guidance to Clinical Operations, Clinical Trial Teams, and Nonclinical teams

What You Bring

Bachelor’s degree in Life Sciences or related discipline required

Advanced degree or formal training in clinical research/quality preferred. GCP and/or GLP auditor certification highly desirable

8-12 years’ experience in GLP and/or GCP Quality Assurance

Strong experience with outsourced studies and CRO oversight

Direct support of GCP/GLP inspections, including FDA BIMO

Knowledge of ICH E6/E8, GLP regulations, and FDA BIMO requirements

Expertise in clinical and nonclinical audit execution

Demonstrated knowledge of data integrity, TMF, and vendor oversight frameworks

Sound judgement and escalation skills

Strong stakeholder and vendor communication abilities

Coaching mindset to drive quality culture

#LI-Hybrid

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.

#LI-Hybrid

Salary range

$171,200 — $256,800 USD