Senior Director, Quality Control

🕒 Maio 30

🏄 California – Remoto

🏄 California – Remote

💵 $230.000 - $270.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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CG Oncology

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2010

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $120.000.000 Series E em 2022-11

Biotechnology • Healthcare Insurance • Pharmaceuticals

A CG Oncology é uma empresa biofarmacêutica clínica em estágio avançado, focada no desenvolvimento e comercialização de imunoterapias oncolíticas inovadoras para pacientes com câncer de bexiga. O principal produto em investigação da empresa, o cretostimogene grenadenorepvec, visa proporcionar uma opção terapêutica que poupa a bexiga, melhorando a qualidade de vida dos pacientes acometidos. Com estudos clínicos em andamento destacando os potenciais benefícios de suas terapias, a CG Oncology busca atender as necessidades não atendidas no tratamento do câncer de bexiga.

Descrição

• Establish and drive the global quality strategy aligned with corporate objectives, regulatory expectations, and risk-based approaches to product development and commercialization. • Develop and lead quality strategy across the product lifecycle (clinical to commercial), ensuring operational excellence, phase-appropriate quality systems, and regulatory compliance. • Represent Quality in strategic discussions and business planning across Technical Operations, Regulatory, and the Executive Leadership Team (ELT). • Serve as quality SME for manufacturing campaigns, CMC strategy, and regulatory submissions (e.g., IND, BLA, supplements). • Lead quality input for QTPP, CQA assessments, control strategies, stability programs, and product specifications.

🎯 Requisitos

• Bachelor’s or master’s degree in a life sciences discipline (e.g., Biology, Chemistry, Engineering) • 10 years in biopharmaceutical Quality roles, including 5+ years in senior leadership • Extensive experience in GxP, biologics manufacturing, late-stage development, and BLA-enabling activities • Strong regulatory experience including authoring/reviewing submissions and representing company in global inspections • Hands-on with product quality systems: CAPA, deviations, change control, batch release, comparability • Demonstrated success working in matrixed environments • High EQ and professional presence • Up to 20% travel (domestic/international)

🏖️ Benefícios

• Health (Medical, Dental, Vision) – PPO & HDHP – Cigna/Principal • Health Spending Accounts - HSA (with Annual Company Contribution), FSA, FSA-DC • Illness & Disability Protection – Company Paid LTD Coverage + Voluntary Plans • Life Insurance – Company Paid 1 x base salary + Voluntary Plans • 401K with 100% company Safe Harbor match up to 4% of base salary • Unlimited Flexible Time Off • Holidays – In 2026 we will observe 14 holidays • Additional exclusive benefits – Voluntary Legal, Pet, Plus More