Manager, GMP Quality

Regulatory Toolkit; Boston (MA); On-site; USD 116,000 - 174,000; Full time

Job summary

Tango Therapeutics is seeking a Manager, Quality Assurance to provide GMP QA oversight for CMC development programs and clinical supply activities. You will partner with Technical Operations, Regulatory, and external manufacturing partners to ensure compliance with global GMP standards as programs advance through development.

In this matrixed environment, you will review batch documentation, lead QA activities across Phases 1–3, identify quality risks, and mentor teams on GMP documentation and

Qualifications

• Bachelor's degree in a science or engineering field plus 5 years in pharma manufacturing, packaging, or lab experience.
• 5+ years QA/compliance in biotech, pharma, lab, CRO or CMO environments.
• Strong knowledge of global GMP regulations (FDA, EMA, ICH) for investigational drug development.
• Experience providing QA oversight across the pharmaceutical lifecycle and GMP documentation.

Responsibilities

• Review batch documentation and dispositions materials for clinical trials.
• Lead strategic GMP QA activities for CMC development programs.
• Ensure compliance with manufacturing, testing, packaging, and distribution regulations and identify gaps.
• Implement phase-appropriate quality guidance and approvals across Phases 1–3.
• Oversee projects, evaluate quality concerns, and resolve GMP compliance issues.
• Identify trends related to development compounds and operations.
• Ensure timely review, approval, and archival of GMP documents.
• Participate in GMP audits of CMOs and vendors; advise on vendor qualification.
• Mentor internal teams on GMP documentation and regulatory compliance.

Skills

GMP regulations

Quality assurance

Cross-functional collab

Regulatory compliance

Education

Bachelor's Degree in Chemistry, Biology, Engineering or related field

Tools

LIMS

EDMS

Job description

Company Overview

Tango Therapeutics is a biotechnologycompanydedicated 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 at201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary

This role will report to the Director of Quality andoperateacross departments, supporting regulated activities and studies. This new role will support CMC development and clinical disposition activities for Tango’s development programs. Tango works in a matrixed, outsourced model where compliance andinspectionreadiness are key to our programs as we advance through the development cycle.

The Manager, QualityAssurance,will provide GMP QA oversight for Tango’s CMC development programs and clinical supply activities. This role partners cross-functionally with Technical Operations, Regulatory, and external manufacturing partners to ensure compliance with global GMP requirements while supporting the advancement of investigational therapies through clinical development.

Your Role:

• Review batch documentation and dispositions materials for use in clinical trials
• Lead & manage strategic GMP QA activities associated with Tango CMC development programs
• Ensure compliance with regulations related to manufacturing, testing, packaging & distribution of investigational drugproductsand active pharmaceutical ingredients.Identifycompliance gaps andproposesolutions
• Execute and lead implementation of phase-appropriate quality guidance, review, and approval processes for product development programs across Phases 1-3
• Oversee projects independently,identifying, evaluating, and resolving product quality concerns in compliance with GMP requirements
• Identifytrends related todevelopmentcompounds, operations, etc.
• Ensuretimelyreview, approval, and archival of GMP documentation and quality records
• Participate in GMP audits of CMOs, contract laboratories, and other vendors, providing recommendationsregardingvendor qualification and continued use
• Mentor and support internal teams on GMP documentation, quality practices, and regulatory compliance
• Additionalduties and responsibilitiesas assigned

What You Bring:

• Bachelor's Degree in Chemistry, Biology,Engineeringor related field plus5years pharma manufacturing,packagingor laboratory experience
• At least 5 years of direct QA/compliance experience working in biotechnology, pharmaceutical, laboratory, CRO or CMO environment
• Strong knowledge of global GMP regulations (FDA, EMA, ICH) applicable to investigational drug development.
• Experience providing QA oversight of drug product development across the pharmaceutical lifecycleThorough understanding of creation/ review/ approval of GMP documents such as specifications, test methods, stability protocols, batch records, and investigations
• Ability to collaborate effectively in a matrixed, cross-functional, and global environment.
• Strong oral/written communication skills
• Capable of analyzing a wide variety of information and data to make management decisionsregardingpotential risks associated with product quality or regulatory compliance
• Able toestablishprofessional relationships and rapport with internal and external peers and experience working collaboratively with teams in a complex,matrixed,and global environment.
• Strong attention to detail and commitment tomaintaininghigh quality and compliance standards.
• Strong project management and organizational skills, with the ability to manage multiple concurrent priorities.

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.

Salary range

$116,000-$174,000 USD