GMP Quality Assurance Manager - CMC & Clinical Supply

Tango Therapeutics; Boston (MA); On-site; USD 116,000 - 174,000; Full time

Job summary

Tango Therapeutics in Boston is seeking a Manager, Quality Assurance to oversee GMP QA activities for CMC development programs, partnering with Technical Operations, Regulatory, and external manufacturers to ensure compliance across the development lifecycle.

You will review batch documentation, drive phase-appropriate quality processes, mentor teams, support audits, and help maintain inspection readiness in a matrixed global environment.

Qualifications

• Bachelor's Degree in Chemistry, Biology, Engineering or related field plus 5 years pharma manufacturing, packaging or laboratory experience
• At least 5 years of direct QA/compliance experience in biotechnology, pharmaceutical, laboratory, CRO or CMO environments
• Strong knowledge of global GMP regulations (FDA, EMA, ICH)
• Experience providing QA oversight across the pharmaceutical lifecycle with GMP document familiarity
• Ability to collaborate effectively in a matrixed, cross-functional, and global environment
• Ability to analyze data to assess potential risks to quality or regulatory compliance
• Ability to build professional relationships with internal and external peers in a complex environment
• Strong attention to detail and commitment to high quality and compliance
• Strong project management and organizational skills with multiple priorities

Responsibilities

• Review batch documentation and dispositions materials for use in clinical trials
• Lead & manage strategic GMP QA activities for Tango CMC development programs
• Ensure compliance with regulations related to manufacturing, testing, packaging & distribution of investigational drugs and APIs
• Execute and lead phase-appropriate quality guidance, review, and approval processes for product development (Phases 1–3)
• Oversee projects independently, resolving product quality concerns in line with GMP
• Identify trends related to development compounds and operations
• Ensure timely review, approval, and archival of GMP documentation and quality records
• Participate in GMP audits of CMOs and vendors, offering vendor qualification recommendations
• Mentor and support internal teams on GMP documentation and regulatory compliance
• Handle additional duties as assigned

Skills

GMP knowledge

QA oversight

Regulatory compliance

Cross-functional collaboration

Documentation review

Audit readiness

Vendor qualification

Quality systems

Project management

Attention to detail

Education

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

Job description

Tango Therapeutics in Boston is seeking a Manager, Quality Assurance to oversee GMP QA activities for CMC development programs, partnering with Technical Operations, Regulatory, and external manufacturers to ensure compliance across the development lifecycle.

You will review batch documentation, drive phase-appropriate quality processes, mentor teams, support audits, and help maintain inspection readiness in a matrixed global environment.