open positions

Manager, Clinical Quality Assurance

Location: Boston, Massachusetts, 02129, United States
Full-time

About Finch

Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.

With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for recurrent C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn’s disease, respectively.

 

Position Summary

The Manager, Clinical Quality Assurance (CQA) supports Finch’s clinical quality compliance programs by providing Good Clinical Practice (GCP) compliance oversight and guidance to multifunctional teams conducting Finch’s clinical trials.  Also, as member of the Quality team, this position will assist in establishing, implementing and maintaining quality assurance systems in support of all phases of the company clinical trials, including clinical vendor management program, inspection readiness program, and Risk-Based Quality Management.

 

Responsibilities

  • Manage Finch’s clinical compliance oversight program, including Clinical Study Audit Plans. Ensure that the audit plan is implemented, in order to provide assurance that Finch sponsored clinical studies are of the required quality standard and in compliance with FDA Regulations and Guidance, global Regulatory Standards and associated ICH Guidelines, Finch study protocols, and relevant Finch SOPs.
  • Manage Finch’s clinical vendor compliance oversight program and GCP Approved Vendor List. Manage or conduct quality system audits of external GCP vendors, internal GCP processes and documents, and clinical investigator sites.  Ensure that audit results are formally and consistently recorded and reported, monitor trending and ensure that corrective/preventive actions have been requested and documented effectively.
  • Contribute to the Finch GCP inspection readiness team, including inspection readiness planning, facilitating completion of inspection readiness tools, and inspection hosting and management.
  • Manage vendors and CROs compliance issues in collaboration with clinical study teams.
  • Manage GCP Training internally and at clinical study investigator meetings
  • Manage the quality aspects of all cross-functional areas involved in Finch clinical studies, including Risk-Based Quality Management processes and pharmacovigilance activities.
  • Report KPIs to senior management on an ongoing basis. Recommend and implement process improvements to internal programs as indicated by audit observations, new regulations, guidance documents, and industry standards.
  • Participate in SOP development for processes that support the compliance oversight programs.

 

Qualifications

  • GCP experience working in a pharmaceutical or biotechnology firm or with a CRO for all phases of clinical trials
  • Knowledge of FDA Regulations and Guidance, as well as global Regulatory Standards and associated ICH Guidelines
  • Experience conducting GCP audits and effective follow up
  • Working knowledge of quality risk management concepts
  • Experience supporting regulatory authority inspections
  • Demonstrated experience in managing and supporting quality systems
  • Knowledge and understanding of drug development and the clinical trial process
  • Strong written and oral communication skills
  • Ability to work independently, with minimal supervision

 

More About Finch

Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we’ll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.

  • Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
  • We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA include an in-office gym with a shower and towel service (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team.

 

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool.  All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.