Associate Director, Quality Assurance, GCP

🕒 Fevereiro 28

🏄 California – Remoto

🏄 California – Remote

💵 $150.000 - $186.000 / 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

• support the Good Clinical Practice (GCP) Quality Assurance (QA) function • perform day-to-day GCP QA operations • execute and/or ensure proper oversight of GCP QA activities • perform external and internal audits • support clinical phase 1 to phase 4 study team activities • review documents • support regulatory inspections • enhance GCP QA infrastructure development • manage or perform clinical site, internal, TMF, GCP, and GLP vendor audits • generate and/or review GCP and GLP QA audit plans and schedules • generate and/or review and approve audit trend reports across programs • communicate, address, and prevent identified GCP compliance issues and trends • develop and manage audit programs • represent QA at program-wide meetings • serve as point of escalation for GCP compliance issues • embed Quality ‑ by ‑ Design (QbD) and Critical ‑ to ‑ Quality (CtQ) principles into study planning and execution • investigate, manage, and track GCP CAPAs, deviations, and other quality issues • collaborate with cross-functional teams • assist with serious breach assessments and notifications • provide guidance and support to Trial Master File activities • review study-specific documents • partner with cross-functional groups and promote compliance • attend governance meetings • identify and address quality systems gaps • author, review, or revise SOPs, Work Instructions, Policies, and Job Aids • deliver training to internal and external stakeholders • support regulatory inspections and inspection readiness activities • prepare clinical sites for inspection readiness • draft and recommend Quality Agreements for GCP/GLP vendors • direct/supervise personnel; including coaching, mentoring, development, and performance management

🎯 Requisitos

• Bachelor’s degree in a science discipline • at least 10 years’ experience in a QA function within the pharmaceutical/biotech industry • minimum of 7 years’ supervisory/leadership experience • minimum of 5 years of working in a QA GCP function • previous experience in inspection readiness and audits • previous experience in developing and implementing compliance activities • proven ability to cultivate and develop relationships with cross functional teams, vendors, sites, and other stakeholders • proven ability to interpret applicable FDA, EU and ICH guidelines related to GCP • strong working knowledge of GCP regulations • ability to assess issues, perform thorough analysis on complex investigations, and resolve issues in a diplomatic and expeditious manner • GVP and GLP knowledge, a plus • Auditor certification and/or RQAP-GCP certification, a plus

🏖️ Benefícios

• discretionary annual target bonus • stock options • ESPP • 401k match • top-notch health insurance plans for employees (and their families) • medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • winter company shutdown