Director, Clinical QA and Compliance

Cambridge, Massachusetts, United States Full-time

Evelo Biosciences is seeking a talented and experienced Director, Clinical QA and Compliance to join our dynamic team.

Evelo Biosciences is a fast-paced company discovering drugs based on the previously unexplored biology of the interactions between the gut and the rest of the body: gut-body network.  We are developing a new class of medicines that could change the standard of care of many major diseases for the great benefit of large numbers of patients worldwide.  These medicines are designed to act on the gut-body network – monoclonal microbials. They are single strains of human commensal microbes which use naturally evolved pharmacology to work in the gut for effects throughout the body, providing effective, convenient and safe medicines to address the unmet needs of huge numbers of patients.

As a key member of the Quality Assurance department, the Director, Clinical QA & Compliance  will be responsible for developing and implementing GCP procedures to manage Evelo’s clinical quality programs. This individual will be the subject matter expert in GCP, develop standards and partner with Clinical Operations, Non-Clinical Development, Contract Research Organization (CRO) and other clinical vendors to establish risk-based GCP quality systems processes and procedures. This position will serve as the key point of contact representing Evelo GCP QA on various projects, liaising with CROs, Partners and various regulatory agencies on GCP related matters, in partnership with the regulatory manager. The successful candidate will be self -motivated and directed; able to work independently as well as in a team environment. Must have excellent knowledge of EU and FDA regulatory landscape and trends and be able to proactively communicate this knowledge to internal stakeholder.

Primary Responsibilities:

  • Develop quality systems SOPs for GCP to manage clinical studies program for the US and globally including oversight of GCP activities managed by Evelo CROs and contracted vendors.
  • Verify clinical trials data to ensure trials are conducted in accordance with applicable study protocols, and in compliance with GCP and ICH guidelines.
  • Partner with Supply Chain, Clinical Research, Product Development departments and CROs to identify and implement GCP procedures in compliance with GCP regulations/guidelines.
  • Establish quality agreements with clinical CRO and other vendors managing Evelo’s clinical studies.
  • Manage clinical product complaints, quality incidents and CAPA associated with GCP and clinical trial material (CTM).
  • Partner with the supply chain to manage processes at the clinical packaging vendors, responsibilities include review and approval of master packaging records, executed batch records, specifications, investigations, CAPA and drug shipment.
  • Manage GLP/GCP audit program for the clinical studies
  • Develop audit plans and conduct GCP and GLP compliance audits for e.g., investigator sites, CRO facilities, depots and other clinical vendors for study-specific compliance (as required).
  • Create key quality metrics for tracking and trending data related to GCP activities, report metrics and significant quality incidents to QA management.
  • Conduct and coordinate GCP compliance training to internal and external customers (as required).
  • Sponsor initiatives to ensure continuous improvement of QA systems
  • Support inspection readiness preparations (internal and external) including hosting and interacting with regulatory agencies during inspections on GCP related matters.
  • Manage other QA responsibilities in GLP and GMP functions, as assigned by the Head of Quality. 

 Qualifications/Experience:

  • Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.
  • A minimum of 10 years in QA managing GCP, GVP or GLP, functions either in small and/or big pharma
  • Authoring and implementing GCP procedures, reviewing clinical packaging batch records including final release of CTM for open label and double-blind studies.
  • Strong working knowledge of, GCP, GVP and GLP regulations and IVRS is preferred.
  • Managed GCP Quality functions for drug/device covering all phases of clinical study program (Phase I to III).
  • Conducted GCP audits and actively participated in regulatory inspections.
  • Proactive in identifying opportunities along with strong problem solving and negotiation skills.
  • Hands on execution of all aspects of quality assurance functions in support of GCP activities in an entrepreneurial, fast paced environment.
  • Highly collaborative with the proven ability to work in a cross-functional team.
  • Strong verbal, written communication skills and computer skills are required.
  • Ability to undertake domestic and international travels up to 40%.

About Evelo Biosciences

Evelo Biosciences, Inc. is a clinical-stage biotechnology company developing a new modality of medicine, monoclonal microbials, which are designed to act on the gut-body network. Evelo’s product candidates are orally-delivered, single strains of microbes, selected for their defined pharmacological properties. They are intended to modulate systemic immunology and biology by acting on multiple naturally evolved biological pathways through the gut-body network. Evelo believes that monoclonal microbials have the potential to be broadly applicable across many diseases including immunoinflammatory, cancer, autoimmune, metabolic, neurological and neuroinflammatory diseases.

Evelo currently has three product candidates, EDP1066 and EDP1815 for the treatment of inflammatory diseases and EDP1503 for the treatment of cancer, for which ten clinical readouts are expected during 2019 and 2020. Evelo is also advancing additional candidates through preclinical development in other disease areas.

For more information, please visit www.evelobio.com

Apply for this opening at http://evelobio.recruiterbox.com/jobs/fk01nfg?apply=true