Quality Management System Lead
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. Own and continuously improve the QMS framework to ensure processes, document control, training, and quality records support consistent compliance across functions and regions.
Requirements
- Bachelor’s degree in Life Sciences, Quality, or related discipline (required)
- 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
Nice To Haves
- Quality-related certification preferred (e.g., ASQ, ISO Lead Auditor, Quality Systems)
- Training in electronic QMS platforms advantageous
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
