GCP & GLP QA Lead (Nonclinical & Clinical Quality Assurance)

Tango Therapeutics; Boston (MA); On-site; USD 171,000 - 257,000; Full time

Job summary

Tango Therapeutics, a Boston-based biotechnology company, seeks a Director, GCP & GLP QA to lead quality assurance across clinical and nonclinical programs, ensuring compliance with GCP, GLP, and global regulatory standards. You will oversee audits, inspections, vendor quality management, and CAPA programs while partnering with internal teams and external partners.

You will drive qualification activities for CROs and labs, support regulatory submissions, and guide QA strategy to sustain quality

Qualifications

• 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.

Responsibilities

• 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

Skills

Quality Assurance

GCP/GLP Audits

FDA BIMO & Inspections

Vendor Oversight

Stakeholder Communication

Coaching & Training

Education

Bachelor\u2019s degree in Life Sciences

Advanced degree or formal training in clinical research/quality

GCP/GLP auditor certification (desirable)

Job description

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.

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

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.

Salary range

$171,200—$256,800 USD