Director, GCP Quality Assurance

Research & Development 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.  We are currently expanding our remit into other autoimmune disorders.  The company is also using its DECODE platform to discover infectious disease antigens and responding T cell clones.

Role Overview

The Director of Clinical Quality Assurance (QA) will be responsible for conducting all Good Clinical Practice (GCP) Quality Assurance activities.  This individual will oversee, develop, assess, and directly work to continuously improve GCP quality processes and to support the state of GCP compliance.  This is an opportunity to help develop the GCP QA function and ensure high quality execution of clinical trials from first in human through commercial marketing authorization.  This person will manage cross functional relationships with internal and external stakeholders and be the Quality Assurance representative to clinical teams.

Key Responsibilities

  • Contribute to the development, authoring, implementation, and maintenance of GCP Quality Systems and Standard Operating Procedures (SOP).
  • Provide consultation for the interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study.
  • Ensure clinical development activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standards.
  • Identify QA and compliance related issues and implement solutions to ensure timelines are maintained.
  • Continue to develop as subject matter experts (SME) for areas of responsibility during regulatory inspections and assist in managing inspection Ready-Room activities.
  • Oversee the conduct of the GCP vendor procedures.
  • Support clinical quality oversight activities for multiple programs within clinical development.
  • Support the clinical research, clinical operations, drug safety & pharmacovigilance, and regulatory teams, contribute to the design and implementation of a risk-based clinical QA management system.
  • Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management.
  • Assist with preparations for GCP/GPvP inspection-readiness for corporate as well as contract research organizations (CROs) and investigator sites.
  • Assist with managing GCP/GPvP Inspections.
  • Review key safety, clinical, and regulatory documents such as DSUR, IB, IND, and NDA.
  • Assist and/or oversee consultant mediated audits; develop, recommend, and follow up on corrective actions.
  • Work collaboratively across the company to improve company QA processes and tools.
  • Plan and conduct complex audits/mock inspections in agreement with QA management.
  • Manage development of risk-based auditing schedules.
  • Train and mentor staff on global GCP regulations and guidance.
  • Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.

Qualifications/Experience

  • A Bachelor's Degree or an M.S. (or Ph.D.) in a clinical/medical science, is strongly preferred, with 8 plus years of relevant industry experience.
  • Experience in supporting Regulatory Authority GCP Inspections; supporting BIMO inspections is preferred.
  • Continue to develop experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area including applicable GxP auditing.
  • Has lead document review (source data verification) initiatives (for example: DSUR, IB, NDA, CSR, etc.), deploying both internal and external resources, in a compressed timeline to meet corporate objectives.
  • Excellent communication, writing, and presentation skills for effectively interfacing with internal and external organizations, collaborators, and customers.
  • Demonstrated ability to work independently and in a team environment and seek resources, as necessary.
  • Ability to assess complex issues, break down into components, and propose viable solutions.
  • Demonstrated ability to lead and organize cross-functional team meetings.
  • Ability to foster effective relationships with vendors, investigators, and colleagues.
  • Excellent knowledge of Global GCP regulations and industry standards.
  • Proficiency in study monitoring activities.
  • Knowledge of the infrastructure and operational characteristics of CROs and centralized services.

 

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, our work requires the creativity and ingenuity of a diverse workforce.  We believe in actively pursuing equity 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 take action as a company where we can make a difference.

Repertoire is proud to be an Equal Opportunity Employer.