GCP & GLP QA Lead (Nonclinical & Clinical Quality Assurance)
Tango Therapeutics
August 22, 2026
On-site
Boston, MA
Clinical Research and Development
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 for clinical/nonclinical inspections (BIMO, GCP, GLP), including mock inspections and evidence room support
- Coordinate responses to clinical/nonclinical inspection observations
- 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, escalation skills, and strong stakeholder/vendor communication
- Coaching mindset to drive quality culture
Salary range
- $171,200—$256,800 USD
- 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 for clinical/nonclinical inspections (BIMO, GCP, GLP), including mock inspections and evidence room support
- Coordinate responses to clinical/nonclinical inspection observations
- 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, escalation skills, and strong stakeholder/vendor communication
- Coaching mindset to drive quality culture
Salary range
- $171,200—$256,800 USD