Manager, Commercial Quality Assurance

🕒 Maio 9

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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

• Support the development, improvement, and management of QA programs, policies, and procedures to ensure cGMP compliance. • Serve as the QA contact for specified vendors, contract facilities, or joint development collaborators. • Perform QA review of manufacturing records, validation related records, batch records, and documents submitted to regulatory agencies. • Lead cGMP auditing of vendors. • Provide input on the vendor’s Quality System events, including change control, deviations, investigation, out-of-specifications, and CAPAs.

🎯 Requisitos

• BS/BA in a relevant scientific discipline. • At least five (5) years of experience in Quality Systems and Quality Assurance processes, including development and documentation. • A minimum of three (3) years demonstrating management of QA projects including directing and organizing personnel to complete critical timeline objectives. • Experience with commercial drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry. • Experience of managing contract manufacturers with direct operational QA oversight responsibilities

🏖️ Benefícios

• HIGHLY COMPETITIVE SALARIES • ANNUAL PERFORMANCE/MERIT REVIEWS • ANNUAL PERFORMANCE BONUSES • EQUITY • SPECIAL RECOGNITION • FULLY REMOTE WORK ENVIRONMENT • REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off • HOLIDAYS – In 2026 we will observe 14 holidays • RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary • 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 • ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More