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Director, Clinical Quality Assurance
Scorpion Therapeutics
- United States
- United States
About
Director, Clinical Quality Assurance. The Director will provide thorough knowledge of GCP Quality, strong leadership and clinical development experience to support Celldexs 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
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 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
Bachelors degree or higher in a relevant field (science or healthcare preferred)
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Languages
- English
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