SummaryThe 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
Salary range
$171,200-$256,800 USD
