Director, Clinical Quality Assurance
3 weeks ago
Overview 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 Celldexs 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 Bachelors 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. #J-18808-Ljbffr
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Director, Clinical Quality Assurance
4 weeks ago
New Haven, United States BioCT Innovation Commons Full timeOverview 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...
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Director, Clinical Quality Assurance
1 week ago
New Haven, CT, United States Celldex Full timeOverview 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...
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Director, Clinical Quality Assurance
5 days ago
New Haven, CT, United States Celldex Full timeOverview 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...
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Director, Clinical Quality Assurance
2 weeks ago
New Haven, CT, United States Celldex Full timeOverview 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...
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Director, Clinical Quality Assurance
3 weeks ago
New York, United States NY Staffing Full timeDirector, Clinical Quality Assurance At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our...
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System Director, Quality Assurance
5 days ago
New Haven, CT, United States Saint Francis Health System Full timeCurrent Saint Francis Employees - Please click HERE to login and apply. Full Time Days Schedule: Monday - Friday | 8:00am - 5:00pm Job Summary: The System Director of Quality Assurance plans and directs activities of the Quality Assurance areas of the Saint Francis Health System for the purpose of facilitating and improving disease management and clinical...
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System Director, Quality Assurance
1 week ago
New Haven, CT, United States Saint Francis Health System Full timeCurrent Saint Francis Employees - Please click HERE to login and apply. Full Time Days Schedule: Monday - Friday | 8:00am - 5:00pm Job Summary: The System Director of Quality Assurance plans and directs activities of the Quality Assurance areas of the Saint Francis Health System for the purpose of facilitating and improving disease management and clinical...
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System Director, Quality Assurance
2 weeks ago
New Haven, CT, United States Saint Francis Health System Full timeCurrent Saint Francis Employees - Please click HERE to login and apply. Full Time Days Schedule: Monday - Friday | 8:00am - 5:00pm Job Summary: The System Director of Quality Assurance plans and directs activities of the Quality Assurance areas of the Saint Francis Health System for the purpose of facilitating and improving disease management and clinical...
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New York, NY, United States Eisai Full timeA pharmaceutical company in New York is seeking a Director of Clinical Quality Assurance to manage clinical quality strategies and compliance with regulations. Considering making an application for this job Check all the details in this job description, and then click on Apply. Candidates should have extensive experience in clinical research and GCP...
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Director of Quality Assurance and Compliance
6 days ago
New York, United States Daybreak Independent Services, Inc. Full timeDirector of Quality Assurance and Compliance About Daybreak Independent Services, Inc. In 2010, Daybreak Independent Services opened its doors for individuals with developmental disabilities to learn and apply their skills in a traditional work setting. Since then, Daybreak has expanded its mission to multiple locations adding both people and additional...
