Vice President, Head of Quality

The Vice President, Head of Quality is responsible for the strategic development and execution of the Company’s quality assurance program and is accountable for the execution and administration of the GXP Quality Systems to support GMP, GLP, and GCP compliance in accordance with ICH, US and EU regulations. The VP will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and responsibilities and provide leadership and guidance to the organization on global quality matters. This position requires expertise in current Good Manufacturing Processes (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) and relevant regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies.

Elicio is a growing organization based out of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States.

This position allows for hybrid work with 2-3 days/week requiring onsite attendance.  Fully remote can be considered for the right candidate depending on proximity to the office.

Major Duties/Responsibilities

  • Ensure that the Quality System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
  • Ensure quality metrics comply with best industry standards and practices.
  • Maintain an effective Quality governance and continually improve governance to meet business and compliance needs.
  • Ensure overall Quality and Compliance oversight for manufacturing, supply chain, nonclinical and clinical.
  • Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
  • Establish strong working relationships with external manufacturers of our products and assure alignment of our Quality Systems and requirements with these CDMOs. Ensure products manufactured at CDMOs meet company quality standards and government regulations.
  • Establish, maintain, and oversee internal Quality Management Systems. Continually establish and improve quality systems, initiatives, priorities, and timelines.
  • Ensure appropriate quality criteria built into selection, implementation or upgrading of electronic systems used to support any GXP related activities.
  • Provide appropriate Quality oversight of external suppliers (CMOs, CROs, etc.).
  • Plan and oversee day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.
  • Keep abreast of industry developments, forthcoming regulations, guidance, best practices etc.
  • Counsel, train and interpret quality requirements to ensure we and our GxP suppliers maintain a state of compliance.
  • Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
  • Responsible for supplier/vendor qualification audit and inspection management.

Education & Professional Experience

  • 15+ years of relevant experience in GxP, QA management or QA leadership positions in a Biotech and/or Pharmaceutical industry.
  • Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities
  • Familiar with ICHQ9 principles and has demonstrated the ability to utilize Quality Risk Management principles in everyday practice.
  • A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members
  • Pro-active in identifying opportunities with a strong solution minded approach and flexibility to emerging challenges based on scope and growth of the organization.
  • Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management.
  • Ability to prioritize competing activities and manage resources and budget accordingly.
  • Doctorate degree preferred in Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.

Working Conditions:  Busy office/lab environment with frequent deadlines and interruptions

Travel: Approximately 5-10% for site visits, audits, and corporate events.

Physical Requirements: Subject to periods of sitting or standing, vision is required to monitor data.

To Apply: Please submit your resume to using the job title in the email subject line.

About Elicio Therapeutics

Elicio Therapeutics is advancing the Amphiphile technology across immunotherapy platforms to defeat cancers and infectious diseases. By combining expertise in materials science, immunology, and immuno-oncology, Elicio is engineering potent Amphiphile immunotherapies that precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated.  Elicio is engineering lymph node targeted cell therapy activators, immunomodulators, adjuvants and vaccines for an array of aggressive cancers and infectious diseases. The Amphiphile platform emerged from laboratories of Darrell Irvine, Howard Hughes Investigator and Professor of Biomedical Engineering in the Koch Institute of Integrative Cancer Research at MIT. For more information, please visit

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the “brain center” of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence.  Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease.  This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms.  By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses.  This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.