Director, Clinical Quality Assurance

OverviewJoin to apply for the Director, Clinical Quality Assurance role at Celldex.Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory, and autoimmune disorders. The Director, Clinical Quality Assurance will provide thorough knowledge of GCP Quality, strong leadership and clinical development experience to support Celldex’s expanding portfolio. The Director of Clinical Quality Assurance will be relied upon as a subject matter expert in GCP and Clinical Compliance with respect to the planning, execution, and close-out of clinical studies. This role will involve ongoing interaction with internal project team members, vendors, and partners, influencing these internal and external stakeholders to successfully embed a robust GCP Quality Assurance culture.ResponsibilitiesExecute and oversee the clinical development oversight program across Clinical, Medical and Regulatory, and implement quality practices throughout clinical trial executionParticipate in the establishment, maintenance and improvement of the Clinical Quality Management System and associated practicesDetermine, evaluate and investigate GCP Quality Events, adequacy of reporting and the potential impact on the studyLead Celldex GCP Inspection Readiness activitiesProvide leadership in GCP inspections performed by FDA and international regulatory agencies; also, audits performed by partnersProactively identify analyses and leverage quality indicators and data for potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategiesProvide business-level leadership, foster best practices, and mentor and consult on GCP compliance techniques across the development and operations organizationsManage the process for documenting Process Deviations, Quality Issues, and CAPAsDevelop and support the issuance of Controlled Documents (e.g., Policy, SOPs, KPIs)Provide suggestions for continuous quality improvement in GxP and, specifically, GCPMaintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed and acknowledged by relevant departments within CelldexResponsible for QA review of key study documentation, SOPs, Vendor documentation, and relevant submission documentationQualificationsBachelor’s degree (or higher) in relevant field. Concentration in a scientific or health care field preferred.7-10 years of experience in the pharmaceutical or life sciences industry, with a strong focus on GCP Quality Management and clinical quality leadership rolesIn-depth knowledge of FDA, EU and ICH guidelines for clinical researchProven track record managing GCP audits, health authority inspections, and inspection readinessExperience in Quality Risk Management for clinical trials and implementation of quality plansExcellent interpersonal and communication skills with the ability to work in a fast-paced, collaborative environmentStrong leadership skillsAbility to work both independently and within a matrix organizationStrategic mindset with strong problem-solving abilitiesOrganized and detail-oriented, with excellent planning capabilitiesAdaptability to changing priorities and deadlinesCelldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.Location: New Haven, CT #J-18808-Ljbffr

Created: 2025-09-17