GMP QA Manager, CMC & Clinical Supply

Regulatory Jobs; 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

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