Director, Quality Systems

🕒 Outubro 27

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $220.000 - $235.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 11%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 16 dias.
• As vagas desta empresa costumam ser preenchidas em 38 dias.

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Achieve Life Sciences

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2015

💊 Farmacêutico

🧬 Biotecnologia

Pharmaceuticals • Biotechnology

A Achieve Life Sciences é uma empresa farmacêutica especializada em fase avançada, focada no desenvolvimento de citisiniclina como tratamento para dependência de nicotina (cessação do tabagismo e vaping). A empresa está avançando com a citisiniclina através dos estudos ORCA Fase 2 e Fase 3 e submeteu um NDA; seu programa clínico visa os receptores nicotínicos para reduzir a abstinência e a satisfação do tabagismo, com o objetivo de oferecer uma nova opção de tratamento aprovada pela FDA para dependência de tabaco e nicotina.

Descrição

• Lead the development, implementation, and continuous improvement of Achieve’s integrated Quality Management System across GxP activities • Partner with GMP and GCP Quality leaders to establish scalable, risk-based quality processes • Own and improve deviations, CAPA, change control, document control, training, risk management, CSV, and CSA processes • Provide Quality oversight and approval of computerized system validation deliverables and related quality events • Ensure lifecycle management, risk-based validation approaches, and data integrity practices • Establish quality metrics and prepare quarterly dashboards • Lead Quality System Management Reviews and track actions • Oversee complaint intake, logging, investigations, outsourced vendor coordination, and recall procedures • Lead inspection readiness activities and support regulatory inspections and audits • Establish and maintain an effective audit schedule and program • Collaborate with internal stakeholders and external partners • Build scalable, controlled, efficient, and adaptable quality processes for commercialization

🎯 Requisitos

• Bachelor’s degree in a scientific discipline or related field • 8+ years of experience in GxP Quality within the biotechnology or pharmaceutical industry • Experience across GMP and GCP environments • Demonstrated experience leading quality professionals and building, implementing, or managing a Quality Management System • Strong knowledge of enterprise QMS processes and computerized system validation or computer software assurance • Knowledge of lifecycle management and risk-based approaches • Direct experience supporting regulatory inspections, including Pre-Approval Inspections (PAIs) • Strong communication and stakeholder management skills • Experience working in a fast-growing or evolving organization • Quality-related professional certification is preferred • Experience developing and scaling quality systems to support organizational growth or commercial launch readiness is preferred

🏖️ Benefícios

• Annual target bonus • Equity compensation • Medical insurance • Dental insurance • Vision insurance • 401(k) retirement plan • Employee Stock Purchase Plan • Company-paid life insurance • Short- and long-term disability coverage • Paid time off • Paid company holidays • Remote work • Travel of up to 10% for conferences and company meetings

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