Senior Manager, Quality Engineering

🕒 Junho 6

🏄 California – Remoto

🏄 California – Remote

💵 $133.000 - $166.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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Crinetics Pharmaceuticals

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2015

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Crinetics Pharmaceuticals é uma empresa de biotecnologia que desenvolve terapias inovadoras para doenças endócrinas. A empresa está focada em atender necessidades médicas não atendidas, criando tratamentos para condições como acromegalia, síndrome carcinoide, síndrome de Cushing dependente de ACTH, hiperplasia adrenal congênita e outros distúrbios endócrinos. A Crinetics está comprometida em melhorar a qualidade de vida dos pacientes através de ciência de ponta e ensaios clínicos robustos. Seu pipeline inclui candidatos promissores como paltusotina, que foi aceita pelo Food and Drug Administration dos EUA para o tratamento de pacientes adultos com acromegalia. A empresa colabora com profissionais de saúde e partes interessadas para garantir que suas terapias abordem problemas reais de forma eficaz e agreguem valor para os investidores ao entrar em nichos de mercado com necessidades significativas.

Descrição

• Lead the administration and day-to-day execution of the GMP Quality Risk Management (QRM) program across GMP quality, development and commercial operations. • Facilitate structured risk assessments (e.g., FMEA, risk ranking/filtering) with cross-functional SMEs to ensure consistent identification, categorization, and quantification of risk. • Partner with Technical Operations project teams to embed risk-based decision making into: Product development lifecycle, Technology transfer, Process validation and continued process verification, Manufacturing and supply chain activities. • Ensure risks are appropriately documented, trended, escalated, and maintained through their full lifecycle within QMS tools. • Establish and maintain risk registers, dashboards, and metrics to provide visibility into risk profiles and trends. • Drive alignment between QRM outputs and core quality systems (e.g., deviations, CAPA, change control). • Serve as the Quality Engineering representative on project teams or facilitate structured touchpoints with project leads to ensure integration of QRM principles.

🎯 Requisitos

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Engineering or related field) • Minimum of 12 years of experience in Quality Assurance within pharmaceutical/biotech GMP environments • Demonstrated experience in Quality Risk Management methodologies (e.g., ICH Q9, FMEA, risk ranking) • Strong knowledge of GMP regulations and global expectations (e.g., FDA, EMA) • Experience supporting manufacturing, tech transfer, validation, and/or commercial operations • Proven ability to facilitate cross-functional risk assessments and drive outcomes • Strong communication, organizational, and influencing skills • Ability to manage multiple priorities in a fast-paced environment

🏖️ Benefícios

• Health insurance plans for employees (and their families) • Discretionary annual target bonus • Stock options • ESPP • 401k match • 20 days of PTO • 10 paid holidays • Winter company shutdown