Director/Senior Director, GCP Quality Assurance
Tango Therapeutics · Boston, MA
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Role summary
Tango Therapeutics seeks a Director of GCP & GLP Quality Assurance to oversee compliance across clinical trials and nonclinical laboratory operations in Boston. This role leads audit strategy, vendor management, regulatory inspections, and quality events while partnering across the organization to ensure adherence to GCP, GLP, and global requirements. The position reports to the Executive Director of Quality and requires a life sciences degree with preferred advanced training in clinical research or quality.
What they're looking for
- Bachelor's degree in life sciences or related field
- 8-12 years of GLP and/or GCP quality assurance experience
- GCP and/or GLP auditor certification highly desirable
- Direct experience supporting GCP/GLP inspections including FDA BIMO
- Knowledge of ICH E6/E8, GLP regulations, and FDA BIMO requirements
- Expertise executing clinical and nonclinical audits
- Demonstrated knowledge of data integrity, TMF, and vendor oversight frameworks
What you'll be doing
- Define and execute risk-based audit strategy for CROs, sites, vendors, systems, and processes
- Provide QA oversight of GLP studies at contract research laboratories including audits and data integrity checks
- Oversee quality events and deviations impacting GCP/GLP compliance, leading investigations and CAPA development
- Establish vendor and partner QA relationships, ensuring quality agreements and performance monitoring
- Lead preparation for clinical and nonclinical regulatory inspections including mock inspections and evidence room support
Privacy & handoff
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