Senior Quality Assurance Leader

1 week ago


Waltham, Massachusetts, United States TScan Therapeutics Full time

Position Overview:

TScan Therapeutics is a pioneering clinical-stage biotechnology firm dedicated to transforming therapeutic options for patients through the identification of innovative T cells and epitopes. We are in search of a Senior Director of Quality Assurance to spearhead our Quality Assurance initiatives for both in-house and outsourced GMP operations that support our groundbreaking TCR-engineered T cell therapy products. This pivotal role will be part of the Technical Operations and Quality team, reporting directly to the Senior Vice President. Key responsibilities will encompass facilitating immediate IND submissions and clinical manufacturing, recruiting essential talent to enhance the department, establishing a compliant and adaptable Quality Management System (QMS), and outlining growth strategies aligned with the company's overarching goals.

The ideal candidate will possess a robust background in Quality Assurance, with a comprehensive understanding of cGMPs and ICH guidelines pertinent to the manufacturing and testing of human cell and gene therapy products, orphan drugs, or other intricate modalities. We seek an outstanding leader and problem solver who thrives in a dynamic environment and fosters collaborative relationships both internally and externally.

Key Responsibilities:

  • Develop and lead the Quality Assurance team
  • Oversee the professional growth of quality department personnel
  • Manage the Quality Management System
  • Provide strategic direction for ongoing quality initiatives
  • Collaborate with development leaders for GxP operations
  • Supervise lot disposition, incoming receipt, and on-floor QA activities
  • Direct Quality Systems, including document management
  • Manage audits and regulatory inspections
  • Work closely with supply chain and external partners
  • Identify opportunities for QMS enhancements
  • Coordinate investigations, root cause analyses, and change controls
  • Ensure readiness for inspections and timely product releases

Qualifications:

  • 15+ years of relevant industry experience
  • Degree in biological sciences or a related discipline
  • Extensive experience in Quality Assurance and Compliance
  • Proven ability to build effective teams and adaptable systems
  • Strong critical thinking and problem-solving capabilities
  • Exceptional communication skills
  • Experience with manufacturing documentation and regulatory submissions
  • Background in cell and gene therapies is preferred

About TScan:

Founded in 2018 by a team of scientists led by Dr. Stephen Elledge, TScan Therapeutics is at the forefront of developing TCR-engineered T cell therapies for cancer treatment. Our innovative discovery platform enables the rapid identification of peptide antigen targets for T cell receptors, enhancing our understanding of disease mechanisms. TScan is leveraging this platform in oncology to identify new TCR/target pairs and advance them into clinical development.

Join Our Team:

At TScan, we foster a supportive, innovative, and professional atmosphere. We are a driven, passionate, and collaborative organization. If you are a talented individual looking to make a significant impact in the biotechnology sector, we encourage you to consider this opportunity.



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