Quality Management System Lead

Posted 12 Days Ago
Be an Early Applicant
Boston, MA, USA
In-Office
151K-227K Annually
Senior level
Biotech
The Role
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.
Summary Generated by Built In

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

Skills Required

  • Bachelor's degree in Life Sciences, Quality, or related discipline
  • 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 experience
  • GxP training systems and compliance tracking experience
  • Knowledge of 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
  • Quality-related certification (e.g., ASQ, ISO Lead Auditor, Quality Systems)
  • Training or experience with electronic QMS platforms
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The Company
HQ: Cambridge, MA
157 Employees
Year Founded: 2017

What We Do

Tango Therapeutics is a biotechnology company discovering and developing novel medicines targeting cancer vulnerabilities to deliver transformational new therapies for patients. Tango was launched in 2017 with a $55 million Series A investment from Third Rock Ventures. The company has established a robust product engine that leverages advances in DNA sequencing and CRISPR-based target discovery to generate breakthrough medicines that have the potential to provide deeper, more sustained benefit than today’s targeted therapies, and extend the benefit of available immuno-oncology agents. Tango Therapeutics is focused on three areas of drug development, each in well-defined patient populations currently lacking effective treatment options, and each with hallmarks of cancer that have not been targeted yet. These include: loss of tumor suppressor gene function; multiple oncogenic drivers; and immune evasion. What fuels each of Tango’s programs is an increasingly sophisticated ability to utilize synthetic lethality - the interaction between two genes that causes cell death when both are inactivated. In cancer cells, one of these genes is inactivated by mutation; the other will be inactivated by a drug. This approach leaves normal cells largely unaffected, with the potential to greatly enhance anti-tumor efficacy and reduce associated toxicity. Tango’s success will be driven by its depth of understanding of the genetic subtypes of cancer, and corresponding insights into novel drug targets and combinations uniquely relevant to each subtype. By shaping discovery efforts in this way, Tango has the potential to reach the clinic quickly, and with a clear plan for identifying the patients most likely to benefit from each new treatment, an approach that could increase both speed and probability of success in translating novel target discoveries into transformational new medicines for patients.

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