Senior Consultant, Quality (VP-Level)

This individual will serve as an integral consultant with exposure to multiple facets of business operations. The Senior Consultant, Quality will be responsible for helping to set strategic direction and operational oversight of the quality function addressing all aspects of GXP compliance.This consultant ensures all internal processes and external partnerships strictly adhere to global regulatory standards, including FDA, EMA, and ICH guidelines.

This role can be up to 10 hours per week to start.

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

Key Responsibilities Include

Strategic Leadership: Develop and execute a comprehensive quality and compliance vision that aligns with the company’s clinical and commercial objectives.

Quality Management System (QMS): Design, implement, and maintain a robust QMS—including document control, change management, and CAPA (Corrective and Preventive Action) systems—that scales with the company's growth.

GxP Compliance Oversight: Ensure full compliance across all GxP areas, including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).

Regulatory Interaction: Serve as the primary liaison for regulatory health authorities during inspections and audits; lead the strategy for inspection readiness.

External Partner Management: Oversee quality at external vendors, including contract manufacturing organizations (CMOs) and clinical research organizations (CROs), ensuring consistent quality standards and negotiating quality agreements.

Product Disposition: Hold ultimate accountability for the review and release (disposition) of raw materials, intermediates, and final drug products for both clinical trials and commercial sale.

Culture & Talent: Build and mentor a high-performing quality organization while championing a "Quality First" culture across all departments.

Education & Professional Experience

Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy) is required. An advanced degree (MS, PhD, or MBA) is strongly preferred.

15+ years of progressive leadership in quality within the biotech or pharmaceutical industry.

Deep knowledge of global regulatory frameworks (FDA 21 CFR Part 11, 210/211, and ISO standards) and experience in biologics or small molecule manufacturing, and parenteral products. Experience with peptide-based vaccines is a plus.

Proven track record of managing outsourced operations successfully leading organizations through regulatory inspections and commercial product launches.

Must thrive in a fast-paced innovative start-up environment.

Exceptional communication and negotiation skills for interacting with executive teams and regulatory agencies.

Strong risk management and analytical problem-solving abilities.

Strategic thinking with a "hands-on" approach to building quality organizations and quality systems.

Working Model

Weekly hours: This role can be up to 10 hours per week to start. It may increase or decrease over time.

Working Conditions: Busy home office/office/laboratory environment with frequent deadlines and interruptions.

Travel: Travel may be required to the Company’s headquarters a few times per year, if necessary.

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

Work Location: Hybrid preference but will consider remote

About Elicio Therapeutics

Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing a pipeline of novel lymph node-targeted immunotherapies for the treatment of some of the most aggressive cancers. By combining expertise in immunology and immunotherapy, Elicio is harnessing the natural power of the immune system with the AMP technology, which allows for therapeutic payloads to be delivered directly to the lymph nodes, with the goal of enhancing the immune system’s cancer-fighting capabilities. By targeting cancer immunotherapies to the core of the immune response, AMP aims to optimize the lymph nodes’ natural ability to educate, activate and amplify cancer-specific T cells, which are essential for recognizing and eliminating tumor cells. Engineered to synchronize immunity in these highly potent sites, AMP is built to enhance the magnitude, potency, quality and durability of the immune response to drive antitumor activity. The Company’s R&D pipeline includes off-the-shelf therapeutic cancer vaccines ELI-002, (targeting mKRAS-driven cancers) as well as ELI-007 and ELI-008 (targeting BRAF-driven cancers and p53 hotspot mutations, respectively). For more information, please visit www.elicio.com.

About the Amphiphile Platform

Elicio Therapeutics’ proprietary Amphiphile (“AMP”) platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, Elicio has observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based upon preclinical studies. Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships. The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, Elicio has observed lymph node-specific engagement driving immune responses of increased magnitude, function and durability.