Senior Consultant, Quality (VP-Level)
Elicio Therapeutics
Summary
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.
Job description
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.
Requirements
- Bachelor's degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy)
- 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)
- Experience in biologics or small molecule manufacturing and parenteral products
- Proven track record of managing outsourced operations
- Experience leading organizations through regulatory inspections and commercial product launches
- Exceptional communication and negotiation skills
- Strong risk management and analytical problem-solving abilities
- Strategic thinking with a hands-on approach
Company overview
Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company pioneering novel lymph node-targeted immunotherapies for the treatment of high-prevalence cancers. The company's innovative Amphiphile (AMP) platform is designed to enhance the education, activation, and amplification of cancer-specific T cells by targeting lymph nodes, potentially generating more robust and durable immune responses compared to conventional vaccination strategies. Elicio's lead program, ELI-002, is an off-the-shelf vaccine candidate targeting the most common KRAS mutations that drive approximately 25% of all solid tumors, including pancreatic and colorectal cancers. The company's approach combines expertise in materials science, immunology, and cancer therapy to develop next-generation immunotherapies that could transform cancer treatment. With ongoing Phase 2 clinical trials and a pipeline that includes additional vaccine candidates targeting BRAF-driven cancers and p53 hotspot mutations, Elicio is positioned at the forefront of immuno-oncology innovation.