Associate Director – Pharmacovigilance Quality Assurance

🕒 5 dias atrás

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Ionis Pharmaceuticals, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 1989

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Ionis Pharmaceuticals, Inc. é uma empresa biofarmacêutica focada na descoberta e desenvolvimento de medicamentos direcionados a RNA e DNA para tratar doenças graves. A empresa utiliza a química de oligonucleotídeos e insights genéticos para avançar em uma linha de terapias nas áreas de neurologia, distúrbios cardiometabólicos e outras áreas de alta necessidade, conduzindo ensaios clínicos e colaborações comerciais para levar medicamentos aos pacientes. A Ionis enfatiza a inovação científica, a defesa dos pacientes e a responsabilidade corporativa em seus esforços para traduzir a ciência genética em terapias transformadoras.

Descrição

• Support implementation and maintenance of a risk-based GVP-compliant quality program covering clinical trial safety and post-marketed safety processes • Plan, conduct, and/or support end-to-end GVP audits of service providers, business partners, affiliates, and internal PV processes • Prepare and/or review audit reports and communicate findings to auditees, cross-functional representatives, and management • Assess audit responses and CAPA plans, conduct effectiveness checks, and track CAPAs through completion • Develop, review, and revise audit plans, SOPs, guidance documents, templates, and related PV QA documents • Support PV inspection readiness and participate in regulatory authority inspections, partner audits, and external assessments • Assess Health Authority inspection and PV partner audit reports, risks, and recommendations for leadership communication • Provide PV QA guidance and training to internal stakeholders involved in clinical development, patient safety, and PV audit and inspection activities • Monitor GVP regulatory intelligence and support implementation of revised requirements • Provide quality support across Patient Safety and Pharmacovigilance, Clinical Development, Clinical Operations, Regulatory Affairs, and Medical Affairs • Provide quality oversight and input for PASS-related activities, deviations, CAPAs, change controls, investigations, and other quality events • Provide QA oversight for PV service providers across their lifecycle, including qualification, agreements, governance, and risk-based oversight • Support PV QA metrics and dashboards for management oversight, trend evaluation, and risk management • Mentor, support, and/or manage internal and external Development QA personnel • Support cross-GxP QA activities requiring PV expertise • Maintain organization, documentation, communication, and inspection readiness • Use approved company technology, including AI-enabled and digital tools, with human oversight

🎯 Requisitos

• Assistant Director: bachelor’s degree plus minimum 8 years, master’s degree plus minimum 6 years, or PhD plus minimum 3 years of GVP quality assurance or relevant clinical trial safety experience • Associate Director: bachelor’s degree plus minimum 12 years, master’s degree plus minimum 8 years, or PhD plus minimum 5 years of GVP quality assurance or relevant clinical trial safety experience • Experience within the pharmaceutical and biotechnology industry and/or service provider work experience • Healthcare/scientific-related discipline highly desirable • Strong GVP auditing and clinical safety experience, including internal process, business partner, and service provider audits • GCP auditing experience preferred • Working knowledge of international GVP regulations, FDA and EMA pharmacovigilance and clinical trial safety requirements, GCP regulations, health authority guidance, and ICH guidelines • Experience supporting or participating in global regulatory inspections, partner audits, and inspection-readiness activities • Understanding of clinical development, risk-based quality systems, clinical PV, and post-market PV activities • Experience writing, reviewing, and revising SOPs and controlled PV documents • PV service provider oversight, quality agreements, CAPAs, deviations, and change controls preferred • Knowledge of computer system validation and data integrity concepts relevant to GVP/GCP systems preferred • Strong verbal and written communication skills and ability to influence without direct authority • Strong organizational and time management skills with ability to manage multiple priorities • Ability to travel, including on short notice when needed

🏖️ Benefícios

• Excellent benefits package • Remote work arrangement • EEO employer