Director, Clinical Quality Assurance – CQA

🕒 Maio 27

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $210.000 - $235.000 / ano

⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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Immunovant

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2018

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Immunovant é uma empresa focada no avanço de tratamentos para doenças autoimunes através de uma abordagem centrada no paciente. Com a visão de permitir vidas normais para pessoas com doenças autoimunes, a Immunovant aplica sua expertise em ciência para desenvolver e testar novas terapias. A empresa enfatiza as complexas e variadas necessidades em diferentes estágios e severidades das doenças. A Immunovant está comprometida em avançar suas áreas terapêuticas e ensaios clínicos, além de dialogar com pacientes, cuidadores e investidores sobre seus estudos em andamento e iniciativas corporativas.

Descrição

• Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s) and trial(s) to ensure the execution of a phase-appropriate, fit-for-purpose Audit Program • Represent Quality at cross-functional clinical program meetings and Clinical Study Team meetings and operational activities to provide appropriate Quality guidance on GCP compliance matters to internal departments. • Identify, mitigate, or escalate clinical quality risks by leveraging GCP knowledge and best practices across all phases of clinical development. • Maintain program oversight and influence proactive quality management through quality related activities with regard to vendor management, study conduct, and study • Author and/or review QMS controlled documents which may include standard operating procedures (SOPs) in accordance with applicable regulatory requirements (e.g., ICH E6, FDA, EMA, MHRA, local regulations) • Oversee the implementation of appropriate and timely Deviation, Investigations and • Participate in risk review meetings and review study Risk Management • Conduct QA reviews of essential documents including as applicable Clinical Protocols, Study Plans/Manuals, Investigator Brochures, Investigator’s Brochure, for ensuring quality, accuracy, and completeness • Collaborate with internal and/or external stakeholders to ensure management of GCP quality issues, CAPAs, and change controls • Identify process improvements to build compliance into the design and conduct of clinical activities • Actively support the development and deployment of Inspection Readiness/Management program to support competent authority inspections for sponsor and clinical sites & vendors

🎯 Requisitos

• A minimum of Bachelor’s degree in STEM (Science, Technology, Engineering, and Math), and/or allied medical field (Nursing, Pharmacy, etc.) • At least seven (7) years of pharmaceutical/biotech/medical device GCP Quality Assurance (QA), Quality Management or Clinical Compliance experience in Phase 1 – 4 clinical trials including non-interventional studies (experience in immunology trials is strongly preferred) • Strong working knowledge and interpretation of global GxP regulations in drug development from pre-clinical to post-marketing safety, particularly S. FDA/EU and ICH regulations and guidelines • Broad and direct experience with competent authority inspections such as US FDA GCP BIMO Inspections (Sponsors, CROs, and/or Clinical Investigators), Pre-Approval Inspections (PAIs), etc. • Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations • Comprehensive knowledge of the interrelationship among other Quality functions (CMC Quality, Quality Systems, Audit Management, Vendor Management) and other business functional areas (Biostatistics, Clinical Development, Clinical Operations, Clinical Laboratory, CMC Operations, Data Management, Drug Safety and Pharmacovigilance, Regulatory, Supply Chain, and Program Management) to serve as a good business partner.

🏖️ Benefícios

• Equity and other forms of compensation may be provided as part of a total compensation package • Full range of medical, dental, vision, 401k, and other benefits • Unlimited paid time off • Parental leave