Lead design, maintenance, and continuous improvement of the QMS across GxP domains. Oversee document lifecycle, change control, training frameworks, data integrity, metrics, CAPA prevention, audit readiness, and prepare quality review packages while partnering with functional owners to ensure compliance and effectiveness.
Company Overview
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.
Summary
Own and continuously improve the QMS framework to ensure processes, document control, training, and quality records support consistent compliance across functions and regions.
Your Role:
- Define and maintain QMS structure: policies, SOPs, work instructions, templates, and governance
- Ensure harmonization across GxP domains (GMP/GLP/GCP) and alignment with applicable regulations/standards
- Oversee document lifecycle management (authoring standards, review/approval, periodic review, archival)
- Ensure change control processes exist and are followed (QMS changes and cross-functional change impacts)
- Oversee GxP training framework (curricula, assignment rules, effectiveness checks, compliance reporting)
- Partner with functional owners to define role-based training requirements
- Ensure QMS records are complete, traceable, audit-ready, and meet data integrity principles
- Establish metrics and trending for QMS health (cycle time, overdue items, training compliance)
- Lead QMS simplification/optimization, including CAPA prevention initiatives based on trending and learnings
- Prepare Quality Management Review packages: KPIs, risks, audit outcomes, CAPA effectiveness, and improvement plans
What You Bring:
- Bachelor’s degree in Life Sciences, Quality, or related discipline (required)
- Quality-related certification preferred (e.g., ASQ, ISO Lead Auditor, Quality Systems)
- Training in electronic QMS platforms advantageous
- 8–12 years in Quality Assurance or Compliance
- Hands-on experience managing QMS in regulated GxP environments
- Experience supporting QMS-related inspections and audits
- QMS design, lifecycle management, and governance
- GxP training systems and compliance tracking
- Data integrity and document control standards
- Process‑oriented, structured, and detail focused
- Strong communication and training skills
- Ability to simplify complex processes and drive alignment
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
$151,200—$226,800 USD
Tango Therapeutics Cambridge, Massachusetts, USA Office
Cambridge, MA, United States
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