Quality Assurance Manager

Tech Ops Cambridge, Massachusetts


Description

Company Overview

Repertoire Immune Medicines is a clinical-stage biotechnology company working to unlock and direct the remarkable power of the human immune system to prevent or treat cancer, as well as autoimmune and infectious disease.  The company is founded on the belief that the repertoire of T cell receptor (TCR)-antigen codes that drive health and disease represents one of the greatest opportunities for innovation in medical science.  Repertoire scientists created and developed the DECODE and DEPLOY suite of technologies, which allow in-depth characterization of TCR-antigen pairs, and the ability to rationally design and develop novel targeted immune medicines.

From its sites in Cambridge, Mass., and Zurich, Switzerland, Repertoire’s team of more than 120 is creating a new category of immune medicines enabled from its DECODE discovery platform.  The company’s first product in the clinic is a novel multiclonal T cell therapy consisting of T cells derived from the peripheral blood, activated against a curated set of antigens, and armed with a proprietary cytokine.  Repertoire is in clinical-stage immuno-oncology development today, targeting metastatic solid tumors.  In the field of autoimmunity, Repertoire is currently using its proprietary platform to discover novel epitopes and TCRs from patients with type 1 diabetes.  The company is also using its DECODE platform to discover infectious disease antigens and responding T cell clones.

Role Overview

Repertoire is seeking a Quality Assurance Manager to join a highly experienced team dedicated to transforming the treatment of cancer.  The ideal candidate will have a strong understanding of regulatory requirements and industry standards to support daily cGxP activities for clinical stage programs.  This position will develop and maintain the Quality Management System (QMS) and provide Quality Oversight.  S/he initiates and implements quality improvement activities, as appropriate, to raise performance of the company systems and processes.  Additionally, they guide and mentor designated representatives and train company employees regarding their impact on the process streamlining, improvements, and QMS.

Key Responsibilities

  • Review production records for compliance, assuring cGMP’s and company procedures are followed and, if needed, procedures/policies are revised.
  • Generate Quality Metrics review.
  • Trackwise experience is a plus.
  • Oversee complex investigations related to GMP production, testing, and distribution.
  • Development, oversight, and coordination of GMP Quality systems and policies related to GMP operations.
  • Ensure that practices are consistent with quality and regulatory standards.
  • Demonstrate a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
  • Work independently without appreciable direction and exercising latitude in determining objectives.
  • Support an environment of teamwork and collaboration.

Qualifications/Experience

  • A minimum of a B.S. degree in Science, Engineering, or equivalent with at least 8 years of relevant experience in Quality Assurance and/or Quality Operations roles in cGMP biotech and/or pharmaceutical environment.
  • Knowledge of FDA regulations and demonstrated knowledge of root cause analysis.
  • Excellent interpersonal skills along with excellent oral and written communication skills.
  • Ability to multi-task in a fast paced, dynamic environment with changing priorities.
  • Strong work ethic with the ability to meet challenging timelines.
  • Ability to think strategically and tactically, balancing these as workload changes.

 

Repertoire is committed towards social responsibility and developing an inclusive culture.  Much as the power of the immune system lies in the diversity of T and B cells, we believe that our work requires the creativity and ingenuity of a diverse workforce, and we are committed to pursuing that in all facets of the work experience at Repertoire.  We will continue to educate ourselves about the inequities and barriers present in our society and act as a company where we can make a difference.

Repertoire is proud to be an Equal Opportunity Employer.