Senior Manager, Quality Systems

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

The successful candidate will be responsible for the expansion, implementation, and maintenance of the Leap GxP quality systems, management of the quality management system (QMS), and performing vendor qualification and surveillance audits, and other duties as assigned.  This role will collaborate with a cross functional team to ensure best GxP practices are implemented, maintained, measured, and followed internally at Leap.  Initial focus on Quality Systems and document control.

Key Responsibilities

  • Quality Systems: manage Leap’s quality systems, including but not limited to deviations, corrective/preventive actions, document control, approved vendor list, training, change control, material review board, etc. 
  • Ensure adherence to applicable GXP policies and procedures including those directed by the FDA and ICH. 
  • Build on the existing GxP Quality Systems infrastructure to support through Phase 2/3 and commercial/launch. 
  • Assist with Inspection Readiness activities.  Interface with internal experts to support GLP/GCP/GMP compliance and alliance activities.  
  • Design a metrics program.  
  • Document Control: oversee the document life-cycle management using Trackwise.  Manage the QMS/LMS/EDMS and perform the role of System Administrator. 
  • Experience of managing internal Quality Systems.  Advanced understanding of the application of cGMPs to early development and commercial products, FDA regulations, and ICH guidelines.  Hands-on self-starter, able to provide solution minded approach, and flexibility to emerging challenges. 
  • Excellent interpersonal skills, personal integrity, professional manner, and ability to gain respect and develop good working relationships with cross functional personnel at all levels.

Qualifications/Experience

  • Minimum of 7+ years of progressive compliance experience in quality functions in biopharmaceutical/pharmaceutical industry with Quality Systems experience.
  • Preference given to candidates demonstrating QMS experience and managing internal Quality Systems.
  • Advanced understanding of the application of cGMPs to early development and commercial products, FDA regulations, and ICH guidelines.
  • Hands-on self-starter, able to provide solution minded approach, and flexibility to emerging challenges.
  • Excellent interpersonal skills, personal integrity, professional manner, and ability to maintain good working relationships with cross functional personnel at all levels.

 

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.