Manager, GMP Quality

Tango Therapeutics•Boston, MA

4d•$116,000 - $174,000•Onsite

About The Position

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. This role will report to the Director of Quality and operate across 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 and inspection readiness are key to our programs as we advance through the development cycle. The Manager, Quality Assurance, 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.

Requirements

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 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 lifecycle
Thorough 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 decisions regarding potential risks associated with product quality or regulatory compliance
Able to establish professional 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 to maintaining high quality and compliance standards.
Strong project management and organizational skills, with the ability to manage multiple concurrent priorities.

Responsibilities

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 drug products and active pharmaceutical ingredients. Identify compliance gaps and propose solutions
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
Identify trends related to development compounds, operations, etc.
Ensure timely review, approval, and archival of GMP documentation and quality records
Participate in GMP audits of CMOs, contract laboratories, and other vendors, providing recommendations regarding vendor qualification and continued use
Mentor and support internal teams on GMP documentation, quality practices, and regulatory compliance
Additional duties and responsibilities as assigned