Full-Time

Director – GXP Quality

Tango Therapeutics

Tango Therapeutics

51-200 employees

Develops targeted cancer therapies using synthetic lethality

Data & Analytics
Biotechnology

Senior

Cambridge, MA, USA

Required Skills
Communications
Quality Assurance (QA)
Requirements
  • Bachelor's Degree in a scientific discipline; advanced degree preferred
  • At least 8 years in the pharmaceutical industry with 5 years in GCP QA
  • Solid understanding of GCP, GLP, GVP, and ICH clinical requirements
  • Experience with US and international clinical studies
  • Able to travel domestically and internationally approximately 25% of the time
  • Excellent verbal and written communication skills including review of clinical documents
  • Good organizational skills and ability to work independently
  • Collaborative problem-solver
Responsibilities
  • Provide GCP/GLP/GVP QA oversight and support to cross functional teams
  • Schedule, oversee, and follow through routine and non-routine quality assurance audits including: investigator sites, CROs/ vendors, process, system, study project, and document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines; will include conducting audits
  • Chair committee for the development, review, and approval of GCP/GLP/GVP controlled documents
  • Develop and implement detailed audit plans and yearly GCP/GLP/GVP audit schedules
  • Ensure timely and effective follow up of all identified or assigned quality issues
  • Act as a liaison with QA counterpart at CROs/vendors
  • Together with cross functional stakeholders assist in preparing for regulatory inspections
  • Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents
  • Conduct QA review of GLP reports and validation plans
  • Additional duties and responsibilities as required

Tango Therapeutics, a biotechnology firm, stands out due to its unique approach to cancer treatment, utilizing advances in DNA sequencing and CRISPR-based target discovery to develop novel medicines targeting cancer vulnerabilities. The company's focus on synthetic lethality, a method that targets specific genes in cancer cells leaving normal cells largely unaffected, offers a potential for enhanced anti-tumor efficacy and reduced toxicity. Furthermore, Tango's patient-centric approach and deep understanding of genetic subtypes of cancer enable it to identify novel drug targets and combinations, accelerating the development of transformational new therapies for patients with well-defined populations currently lacking effective treatment options.

Company Stage

IPO

Total Funding

$537M

Headquarters

Boston, Massachusetts

Founded

2017

Growth & Insights
Headcount

6 month growth

16%

1 year growth

35%

2 year growth

59%