New · posted Oct 15
Tango Therapeutics · Biotechnology
Director/Senior Director, GCP Quality Assurance
- Boston, MA
- Hybrid
- Full-time
- Director
Open until filled
The role
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.
What you need
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
What you'll do
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
Pay
$171,200 – $256,800 a year
Employer provided$171,200—$256,800 USD
Where you'll work
Boston, MAHybridOpen in Maps (opens in a new tab)
More jobs in Boston, MAFrom the posting
About Tango Therapeutics
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, accessibility and legal noticesTango Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in Massachusetts33 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $171,200 | — | $256,800 |
| Massachusetts (middle half) | $186,000 | $204,500 | $231,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Tango Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Tango Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance14
- Collaboration and leadership9
- Documentation and SOPs3
- Lab testing and methods2
- Investigations and CAPA2
- Regulatory submissions2
- Data and digital systems2
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
Company hiring pulse
Tango Therapeutics on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality3 100%
By level
- Director1 33%
- Manager1 33%
- Senior & Principal1 33%
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Director/Senior Director, GCP Quality Assurance at Tango Therapeutics
Open until filled. $171K–$257K a year, employer provided.