Senior Consultant, Quality – VP Level

Elicio

. Develop and execute a comprehensive quality and compliance vision aligned with the company’s clinical and commercial objectives .

Posted 11/9/2026part-timeBoston • Massachusetts • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in developing and executing quality management systems aligned with clinical and commercial objectives, ensuring compliance with GMP, GCP, and GLP standards. Proven leadership in managing quality operations within the biotech or pharmaceutical industry, with a strong focus on regulatory compliance and inspection readiness.

Highest-signal resume keywords

Quality Management System DevelopmentRegulatory Compliance ExpertiseLeadership in Biotech or Pharmaceutical IndustryInspection Readiness StrategyRisk Management and Analytical Problem-Solving

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemDocument ControlChange ManagementCAPA SystemsGMP ComplianceGCP ComplianceGLP ComplianceFDA 21 CFR Part 11ISO StandardsBiologics Manufacturing

Soft Skills

Exceptional Communication SkillsNegotiation SkillsStrategic ThinkingMentoring AbilitiesProblem-Solving Skills

Industry Keywords

Biotech IndustryPharmaceutical IndustryRegulatory Health AuthoritiesOutsourced Operations ManagementPeptide-Based VaccinesCommercial Product LaunchesQuality AgreementsCROsCMOsQuality First Culture

About the role

Key responsibilities & impact

Develop and execute a comprehensive quality and compliance vision aligned with the company’s clinical and commercial objectives
Design, implement, and maintain a scalable Quality Management System, including document control, change management, and CAPA systems
Ensure compliance across GMP, GCP, and GLP areas
Serve as the primary liaison with regulatory health authorities during inspections and audits
Lead inspection-readiness strategy
Oversee quality at external vendors, including CMOs and CROs
Ensure consistent quality standards and negotiate quality agreements with external partners
Hold ultimate accountability for reviewing and releasing raw materials, intermediates, and final drug products for clinical trials and commercial sale
Build and mentor a high-performing quality organization
Champion a “Quality First” culture across all departments

Requirements

What you’ll need

Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy) is required
15+ years of progressive leadership in quality within the biotech or pharmaceutical industry
Deep knowledge of global regulatory frameworks, including FDA 21 CFR Part 11, 210/211, and ISO standards
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
Experience leading organizations through regulatory inspections and commercial product launches
Ability to 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
Ability to work in a busy home office, office, or laboratory environment with frequent deadlines and interruptions
Ability to meet physical requirements involving periods of sitting or standing and monitoring data visually

Benefits

Comp & perks

Hybrid preference with remote consideration
Flexible weekly hours, up to 10 hours per week initially, with potential to increase or decrease over time
Travel to company headquarters a few times per year, if necessary