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

Company OverviewTango 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.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 RoleDefine 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 oversightProvide QA oversight of GLP studies at contract research laboratories, including facility/study audits and data integrity checksEnsure GLP study documentation supports regulatory submissions and is inspection-readyOversee 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 monitoredSupport 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 supportCoordinate responses to clinical/nonclinical inspection observations in collaboration with stakeholdersEnsure GCP/GLP-related SOPs and training curricula are current, role-based, and effectively implementedProvide coaching and quality guidance to Clinical Operations, Clinical Trial Teams, and Nonclinical teamsWhat You BringBachelor’s degree in Life Sciences or related discipline requiredAdvanced degree or formal training in clinical research/quality preferred. GCP and/or GLP auditor certification highly desirable8-12 years’ experience in GLP and/or GCP Quality AssuranceStrong experience with outsourced studies and CRO oversightDirect support of GCP/GLP inspections, including FDA BIMOKnowledge of ICH E6/E8, GLP regulations, and FDA BIMO requirementsExpertise in clinical and nonclinical audit executionDemonstrated knowledge of data integrity, TMF, and vendor oversight frameworksSound judgement and escalation skillsStrong stakeholder and vendor communication abilitiesCoaching mindset to drive quality culture#LI-HybridWe 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-HybridSalary range $171,200—$256,800 USD