Director, Clinical Quality Assurance

Company: 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. 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.

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.
• Determines, evaluates and investigates 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.
• Provides business-level leadership, fosters best practices, and mentors and consults on GCP compliance techniques across the development and operations organizations.
• Manages 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.

Celldex 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.