Senior Director, Quality Control

🕒 5 days ago

🏄 California – Remote

🏄 California – Remote

💵 $230k - $270k / year

⏰ Full Time

🟠 Senior

👔 Director

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CG Oncology

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2010

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $120M Series E on 2022-11

Biotechnology • Healthcare Insurance • Pharmaceuticals

CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative oncolytic immunotherapies for patients with bladder cancer. The company's primary investigational product, cretostimogene grenadenorepvec, aims to provide a bladder-sparing therapeutic option, enhancing the quality of life for afflicted patients. With ongoing clinical studies highlighting the potential benefits of their therapies, CG Oncology strives to address the unmet needs in bladder cancer treatment.

📋 Description

• 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.

🎯 Requirements

• 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)

🏖️ Benefits

• 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