Director/Senior Director, GCP Quality Assurance
- Pay
- $171,200 – $256,800 per year
- Location
- Boston, MA · Hybrid
- Job type
- Full-time
- Level
- Director
- Experience
- 8+ years
- Education
- Bachelor's degree
- Listed
- 31 days ago
Skills & highlights for this role
- GCP auditor certification
- ICH E6
- GLP regulations
- FDA BIMO
- CRO oversight
- data integrity
Also useful
- TMF oversight
- CAPA
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
- #LI-Hybrid
- #LI-Hybrid
Pay and benefits
Salary range $171,200—$256,800 USD
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.
Equal opportunity and legal notices
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.
From Tango Therapeutics's careers page, first listed on Rolev.ai on October 10, 2026. Rolev.ai is not the employer.
How Rolev.ai helps with this application
Rolev.ai is a job search and application tool for US job seekers. For this Director/Senior Director, GCP Quality Assurance role at Tango Therapeutics, it shows how your resume fits, tailors your resume to the posting, and prepares the application for you to review.
See how you fit
Openings from employer career sites are ranked against your whole resume—and searchable inside Claude, ChatGPT, and Cursor via Rolev.ai MCP.
Tailor without inventing
Every change to your resume is checked against your original. New experience goes in only with your yes—zero fabricated claims.
Draft the full kit
Tailored and Full Match resumes, role-specific cover letters, and answers to employer screening questions are prepared in seconds.
1-Click Extension Autofill
The Chrome extension fills the employer's Greenhouse, Workday, Lever, or Ashby form in 1 click. You review it and press Submit.
Similar roles
- Quality Assurance ManagerSoLa Impact · Los Angeles, CA
- Sr Manager, Audits & Inspections - Quality Systems & ComplianceThermofisher · Greenville, NC
- Sr. Associate III, Compliance - QRM LeadBiibhr · Research Triangle Park, NC
- Director of QualityCertifyOS · Remote (US)
- Manager, Quality AssuranceVwr · Phillipsburg, NJ
- QA Operations - Drug Product, QA ManagerBridgeBio Pharma · San Francisco, CA
Common questions
What is the salary for the Director/Senior Director, GCP Quality Assurance role at Tango Therapeutics?
The Director/Senior Director, GCP Quality Assurance posting at Tango Therapeutics states compensation of $171,200 – $256,800 per year. It is listed as a full-time position. Final pay may depend on location, experience, and interview evaluation on Tango Therapeutics's official career site.
Where is the Director/Senior Director, GCP Quality Assurance job at Tango Therapeutics located?
This Director/Senior Director, GCP Quality Assurance position at Tango Therapeutics is located in Boston, MA (Hybrid). Always check Tango Therapeutics's application page for specific state eligibility or relocation policies.
What qualifications are required for Director/Senior Director, GCP Quality Assurance at Tango Therapeutics?
For the Director/Senior Director, GCP Quality Assurance role, Tango Therapeutics highlights 8+ years of relevant experience; a bachelor's degree; experience with ICH E6, GLP regulations, FDA BIMO, CRO oversight, data integrity. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the Director/Senior Director, GCP Quality Assurance position at Tango Therapeutics?
This listing links directly to Tango Therapeutics's Greenhouse application page. You can apply directly on Tango Therapeutics's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Greenhouse application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.