Director, Clinical Quality Assurance

Role Summary

Director, Clinical Quality Assurance. The Director will provide thorough knowledge of GCP Quality, strong leadership and clinical development experience to support Celldex’s expanding portfolio. A subject matter expert in GCP and Clinical Compliance, you will lead planning, execution, and close-out of clinical studies, interfacing with internal teams, vendors, and partners to embed a robust GCP Quality Assurance culture.

Responsibilities

• Execute and oversee the clinical development oversight program across Clinical, Medical and Regulatory, and implement quality practices throughout clinical trial execution
• Participate in the establishment, maintenance and improvement of the Clinical Quality Management System and associated practices
• Determine, evaluate and investigate GCP Quality Events, adequacy of reporting and the potential impact on the study
• Lead Celldex GCP Inspection Readiness activities
• Provide leadership in GCP inspections performed by FDA and international regulatory agencies; also, audits performed by partners
• Proactively 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 strategies
• Provide business-level leadership, foster best practices, and mentor and consult on GCP compliance techniques across the development and operations organizations
• Manage the process for documenting Process Deviations, Quality Issues, and CAPAs
• Develop and support the issuance of Controlled Documents (e.g., Policy, SOPs, KPIs)
• Provide suggestions for continuous quality improvement in GxP and, specifically, GCP
• Maintain 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 Celldex
• Responsible for QA review of key study documentation, SOPs, Vendor documentation, and relevant submission documentation

Qualifications

• Bachelor’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 roles
• In-depth knowledge of FDA, EU and ICH guidelines for clinical research
• Proven track record managing GCP audits, health authority inspections, and inspection readiness
• Experience in Quality Risk Management for clinical trials and implementation of quality plans
• Excellent interpersonal and communication skills with the ability to work in a fast-paced, collaborative environment
• Strong leadership skills
• Ability to work both independently and within a matrix organization
• Strategic mindset with strong problem-solving abilities
• Organized and detail-oriented, with excellent planning capabilities
• Adaptability to changing priorities and deadlines

Skills

• GCP compliance and quality assurance
• Quality Management Systems and documentation control
• Regulatory inspections and audits (FDA, international authorities)
• Quality risk management and CAPA processes
• Stakeholder influence and leadership in cross-functional teams

Education

• Bachelor’s degree or higher in a relevant field (science or healthcare preferred)